Die HPV-Studie ist bereits geschlossen. Wir nehmen keine weiteren Patienten mehr dafür auf.

Laufende Studien:

Wir suchen noch Patienten für folgende Studiengebiete:

  • bei HIV-Infektion
  • bei Fettleberhepatitis

 

 

 

 

 

About us

Doctors in private practices specialized in treatment of patients with HIV and viral hepatitis along with the department of Internal Medicine / Infectious diseases of the Vivantes Auguste-Viktoria-Klinikum joined to found a research enterprise, ‘EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH’ to form a common network for planning and conducting of research and clinical studies.

The concept of EPIMED is that of an independent clinical research facility. It is the connection of high quality treatment in the (general practitioners or specialists) practice on one hand and the excellent quality of the data acquisition for research purpose on the other hand. We guarantee excellent data for studies phase I / II / III. We are proud to have contributed to the pivotal development of substances especially in the ART research with more than 140 clinical studies in 20 years.

Furthermore, EPIMED is a self-evident member of the so-called ‚Schöneberger Model’ – Berlin’s cooperation of hospitals and specialists in private practices, research and care, prevention and treatment,  AIDS councils and nursing since the begin of the AIDS pandemic.

Please read more about our know-how, our structure and equipment as well as about our offers in the menue For Sponsors.

Last change: 2017-JAN-18

 

Über uns

Berliner niedergelassene Ärzte mit Schwerpunkt in der Versorgung von Menschen mit HIV und viralen Hepatitiden und die damalige Klinik für Innere Medizin / Infektiologie des Vivantes Auguste-Viktoria-Klinikums und aktuell des St. Joseph Krankenhauses haben sich zum Wissenschaftsunternehmen‚ EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH zusammengeschlossen, um ein gemeinsames Netzwerk zur Planung und Durchführung von wissenschaftlichen Vorhaben und klinischen Studien aufzubauen.

Das Konzept von EPIMED ist das einer Independent Clinical Research Facility; die Verknüpfung von guter (haus)ärztlicher Versorgung einerseits und hervorragender Qualität der in den klinischen Prüfungen erhobenen Daten andererseits, die wir bei der Durchführung von Phase I-III Studien gewährleisten. Mit über 140 Studien in 20 Jahren können wir nicht ohne Stolz darauf verweisen, an vielen entscheidenden Entwicklungen von Substanzen, insbesondere in der ART-Forschung, mitgewirkt zu haben.

EPIMED versteht sich darüber hinaus als selbstverständlicher Teil des Berliner „Schöneberger Model“, das mit Beginn der AIDS-Pandemie richtungweisend Kliniken und niedergelassene Ärzte, Forschung und Versorgung, Prävention und Behandlung, AIDS-Hilfen und Pflege miteinander verbindet.

Lesen Sie bitte mehr zu unserem Know-How, zu unserer Struktur und Ausstattung und zu unseren Angeboten im Menü Für Sponsoren.

 

Team Studienzentrale

Dr. med. Christina Sophie Engelhard

Seit Juni 2020 Teamleitung und als medical clinical studies research manager verantwortlich für die generellen, organisatorischen Abläufe in der Studiendurchführung, sowie Ansprechpartnerin für Sponsoren und Kollegen in den peripheren Einheiten. Sie ist ausgebildete Fachärztin für Innere Medizin und stieß im Januar 2019 zum EPIMED-Team, nachdem Sie seit 2014 als Assistenzärztin im Helios Klinikum Berlin Buch in den Bereichen Hämatologie, Onkologie, Tumorimmunologie, Stammzellentransplantation und Intensivmedizin gearbeitet hatte. In enger Zusammenarbeit mit dem Hauptprüfer Dr. Arastéh liegt Ihr Schwerpunkt als Prüfärztin der EPIMED-Zentrale in der Beurteilung neu eingereichter Studien-Protokolle, der Überprüfung der source-data und der Rücksprache mit den Schwerpunktärzten, Sponsoren und CROs. Sie führt Patientenaufklärungen und Screening-Visiten durch, bewertet Laborbefunde und SUA-Reports.

 
Michael Rittweger

Facharzt für Innere Medizin und stellvertretender Prüfer, kam im Jahr 2004 zu EPIMED. Er ist ist heute neben seiner Tätigkeit für EPIMED, niedergelassener Arzt in der praxiswilmersdorfer in Berlin. Er hat seit 2002 zahlreiche klinische Studien inner- und außerhalb von EPIMED betreut.

Josephine Fink

ist seit September 2020 Study-Coordinator bei EPIMED. Sie ist ausgebildete MFA und arbeitete zuvor in einigen Hausarztpraxen, zuletzt war sie in der Kantpraxis mit rheumatologischem und gastroenterologischem Schwerpunkt. Sie betreut eigene Studien beginnend bei der Konzeption und gesamten Durchführung. Mit ihrer äußerst schnellen Auffassungsgabe optimiert sie zudem viel interne Prozesse.

 

 
 
 
Sophia Charlotte Garoes

 

Study coordinator ..

 

 

 

Dietmar Schranz

ist seit 1999 Geschäftsführer der EPIMED GmbH und als niedergelassener Arzt einer Schwerpunktpraxis in Berlin-Charlottenburg von Anfang an beteiligt an EPIMED-Studien. Seine Führungs- und Planungsaufgaben umfassen die Überprüfung der Verantwortlichkeit und Machbarkeit von Studienangeboten und die Leitung der regelmäßigen Studienbesprechungen der beteiligten EPIMED-Studienärzte.

 
 
Priv. Doz. Dr. Keikawus Arastéh

Prüfer, ist zusammen mit Dietmar Schranz Geschäftsführer der EPIMED GmbH mit Schwerpunkt auf der Akquise von Studien. In seiner Funktion obliegt ihm die Gesamtverantwortung über alle Prüfungen bei EPIMED. Seit 1991 führt er Studien im Bereich HIV/AIDS und angrenzenden Indikationsfeldern durch, hat dazu in zahlreichen Fachzeitschriften publiziert und ist Mitautor der Deutsch-Österreichischen Leitlinien zur antiretroviralen Therapie der HIV-Infektion.

Competence and Service

  • An average annual performance of 20 EMA/FDA trials with approximately 150 subjects, both HIV and HCV from phase Ib to phase IIIb, also including pharmacokinetic studies, long term observations and roll-over studies
  • Participation in the development of all mayor ART since 1997 and therapeutic HIV-vaccine trials since 2009
  • Participation in protease/polymerase inhibitor studies for enhanced HCV-treatment since 2008
  • Experienced staff in conducting clinical trials, regularly trained in Good Clinical  Practice, competent in HIV/HCV and associated fields of expertise
  • One full time and one part time investigator, three study-coordinators, a finance and legal officer and relief nurses led by the principal investigator
  • Teaching on GCP courses

Pre-Study

  • Regular attendance of investigator meetings, conferences and trainings
  • Skilled in submitting trials to IRB/EC
  • Thorough pre-screening due to the access to the original subject data provided by the EPIMED associated private practices
  • Constant technical upgrading of data and information technologies for subject privacy and data confidentiality by the company data protection officer
  • Diligent and committed informed consent process and qualified subject handling

Study

  • Highest level of performance in the implementation of every study protocol detail
  • 24 hour surveillance of the patients in pharmacokinetic studies at the outpatient unit at the Immunologische Tagesklinik of the Vivantes Auguste-Viktoria-Klinikum
  • Experienced handling of electronic documentation (eCRF) e.g. InForm, Oracle
  • Long-term experience in the processing and shipment of samples and medication according to protocol requirements
  • Comprehensive support of the monitoring process

Post-Study

  • Accurate post-processing  of trials and secure archiving
  • Permanent qualitiy assurance through six sponsor audits and one helath authoirity inspection over 8 years
  • Numerous publication co-authorships

Last change: 03/07/2016

 

The responsible data controller for our website http://www.epimed.org within the meaning of the EU General Data Protection Regulation is the EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH (→ legal ).

We process personal data, except in the context of a voluntary contact, only in the form of technical processes, plugins, as well as third-party Services.

1. Cookies

www.epimed.org uses an internal cookie: pll_language stores, whether you as a user are presented this website in German or in English.

2. Hosting

Our host, the domainfactory GmbH Oskar-Messter-Str. 33, 85737 Ismaning retains your IP address for 14 days. Their privacy policy: https://www.df.eu/de/datenschutz/

3. Google Maps

We include as a service the maps of the service Google Maps of the provider Google LLC1600, Amphitheatre Parkway, Mountain View, CA 94043, USA. Privacy policy : https://www.google.com/policies/privacy . Opt-Out: https://adssettings.google.com/authenticated. We point out that EPIMED has no influence on the tracking of your personal data by this embedded third-party provider.

4. BVG Web-Widget

We include as a Service the API BVG Fahrplaninfo. Provider is the Berliner Verkehrsbetriebe AöR , Holzmarktstraße 15-17, 10179 Berlin. Privacy policy : https://www.bvg.de/de/Serviceseiten/Datenschutzhinweise-BVGdeOnlineshop . We point out that EPIMED has no influence on the tracking of your personal data by this embedded third-party Provider.

5. Contact Form

The possibility of the use of a contact form exists on our website. The specification of a valid e-mail address is required for this. Other, personal information is optional. With this you give us your consent to respond to you for the purpose of establishing contact. Your e-mail address will be used to assign your inquiry and answer it. The response also lies within our legitimate interest (Art. 6 (1) (f) GDPR). Storage of your voluntarily-provided, further personal data in a database does not take place. After completing your request, your personal data will be deleted. Your data will not be shared with third parties. We point out that complete data security cannot be guaranteed for communication by e-mail.

6. Amendments

We reserve the right to make technical and content changes to our service offer. Should these have consequences for data protection, we will accordingly adjust our privacy policy.

7. Your Rights

As a data subject, you have the following rights at any time:

  • Information about your stored data and its processing,
  • Deletion or correction of your data stored with us,
  • Objection to the processing of your data with us,
  • Possible withdrawal at any time of your consent with effect for the future.

The supervisory authority responsible for complaints is the Berliner Beauftragter für Datenschutz und Informationsfreiheit, Friedrichstr. 219, 10969 Berlin. Our external data protection officer is the Sonnemann / Strelecki GbR, Kronenstraße 77, 44139 Dortmund, +49 231 9786951

Any queries? Write an e-mal to datenschutz@epimed.org

 

 

Disclaimer

1_Taste_gruen_Vorlage

1. Content

The EPIMED Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH (the author) reserves the right not to be responsible for the topicality, correctness, completeness or quality of the information provided on this website. Liability claims regarding damage caused by the use of any information provided, including any kind of information which is incomplete or incorrect, will therefore be rejected. All offers of information are not-binding and without obligation. Parts of the pages or the complete publication including all offers and information might be extended, changed or partly or completely deleted by the author without separate announcement.

2. Referrals and links

The author is not responsible for any contents linked or referred to from his pages – unless he has full knowledge of illegal contents and would be able to prevent the visitors of his site from viewing those pages. If any damage occurs by the use of information presented there, only the author of the respective pages might be liable, not the one who has linked to these pages.

3. Copyright

The author intended not to use any copyrighted material for the publication or, if not possible, to indicate the copyright of the respective object. The copyright for any material created by the author is reserved. Any duplication or use of objects such as images, diagrams, or texts in other electronic or printed publications is not permitted without the author’s agreement.

4. Legal validity

This disclaimer is to be regarded as part of the internet publication which you were referred from. If sections or individual terms of this statement are not legal or correct, the content or validity of the other parts remain uninfluenced by this fact.

Last change: 08/18/2009

Mandatory specifications

Service Provider (Publisher)
EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH Budapester Str. 15-19, D-10787 Berlin, Germany
Commercial Register (GER)
Amtsgericht Berlin-Charlottenburg HRB 64067
Executives (CEOs)
Priv. Doz. Dr. med. Keikawus Arastéh, MD Dietmar Schranz, MD
Fon / Fax
+4930 265 583 70  / +4930 265 583 729
Supervisory Authority (GER)
Landesamt für Gesundheit und Soziales, Berlin
Editor / Webmaster
Bastian Krondorfer Fon +4930 265 583 720
English Version
“For Patients / Preface”, “For Sponsors / Introduction” and “About us” by Jukka Hartikainen, MD; “Disclaimer”, “Privacy Policy” and “For Doctors” by allround Fremdsprachen (DIN EN ISO 9001-2008 certified); B. Krondorfer
Gender Mainstreaming
Masculine gender forms used in this website also include the feminine form except where the context suggests otherwise.

This website is exclusively made to inform about the EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH’s activities in the field of clinical research. On this website EPIMED GmbH does not offer any medical service. In addition we declare, that this website is entirely independent from any funding or lobbying of any sponsor or contractee mentioned in the section “partner” or any other third party. Any statement on this website is invariably intended for public relations and promotion of the EPIMED GmbH. In case, trademarks will be mentioned in the texts for recruitment of patients, this is exclusively meant as evidence of intelligibility of the study-design and not as an advertisment of a medical product or it’s manufacturer.

© 2008 et seq. EPIMED GmbH. All rights reserved

Last change: 04-OCT-2018

Web-Links

Clinical Research Service
Bundesinstitut für Arzneimittel und Medizinprodukte
www.bfarm.de
Berliner Aids-Hilfe e.V.
www.berlin.aidshilfe.de
ClinicalTrials.gov – A service by the U.S. Nat. Institute of Health
clinicaltrials.gov
Deutsche AIDS-Gesellschaft
www.daignet.de/site-Content
EMA – “European Medicine Agency”
www.ema.europa.eu
Deutsche AIDS-Hilfe
www.aidshilfe.de
FDA – “Food And Drug Administration”
www.fda.gov
HIV im Dialog
www.hiv-im-dialog.de
ICH – “International Conference on Harmonisation”
www.ich.org
HIV&more
www.hivandmore.de
hepatitis&more
www.hepatitisandmore.de
Kompetenznetz HIV/AIDS
www.kompetenznetz-hiv.de
Kompetenznetz Hepatitis
www.kompetenznetz-hepatitis.de
NAM-HIV and AIDS Services Worldwide
www.aidsmap.com
Projekt Information
www.projektinfo.de
Vivantes Netzwerk für Gesundheit
www.vivantes.de
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
www.mvz-mib.dewww.mvz-mib.de
Web-Seiten der EPIMED niedergelassenen Studienärzte finden Sie hier.

Last change: 11/17/2015

Last change: 03/09/2016
 

Good Clinical Practice: ICH-GCP

A unified standard for clinical studies, the Guideline for Good Clinical Practice (GCP) is provided and constantly enhanced by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH brings together the health authorities and the pharmaceutical industry from the US, the EU, the non-EU Nordic countries, Japan, Canada, Australia as well as the WHO.

The complete and up-to-date GCP is provided for non commercial purpose by the European Medicines Agency (EMA) at their website:

ICH-GCP

Last change: 08/26/2014

Declaration of Helsinki

The ethical principle for all medical research involving human subjects is the World Medical Association Declaration of Helsinki 1964 as amended by the 59nd WMA General Assembly, Seoul, South-Korea 2008.

pdf Declaration_of_Helsinki_Seoul_2008.pdf 57 K

Last change: 08/18/2009

Study-Archive (excerpts)

CNAB 3002

A randomized, double-blind, comparative, parallel-group, multicentre trial to evaluate the safety and efficacy of 1592U89 versus placebo in combination with background antiretroviral therapy in HIV-infected antiretroviral therapy experienced subjects with CD4+ cell counts ≥ 100cells/mm³ and plasma viral load between 400 copies/ml and 50 000 copies/ml 1997

Peldesine 96-009

Phase I, placebo-controlled study of oral BCX-34 (Peldesine) 1998

Saquinavir SGC G5030 (Racing-Trial)

Pilot Study to evaluate the efficacy and safety of Saquinavir SGC in combination with Zidovudine and Zalcitabine and to optimize the sequence of two different antiviral triple regimes with respect to the development of resistance mutations in HIV-infected patients

M98-863

A randomized, double-blind, phase III study of ABT-378/Ritonavir plus Stavudine and Lamivudine vs. Nelfinavir plus Stavudine and Lamivudine in antiretroviral-naive HIV-infected subjects 1999

M98-888

A randomized, open-label, phase III study of ABT-378/Ritonavir in combination with Nevirapine and 2 nucleoside reverse transcriptase inhibitors (NRTIs) vs. Investigator selected protease inhibitor(s) in combination with Nevirapine and 2 NRTIs in antiretroviral-experienced HIV-infected subjects

MKC-301

A randomized double-blind comparison of MKC-442 versus placebo in antiretroviral-naive patients with HIV-1 RNA 5000 and 50000 copies/ml and CD4+ ³300 cells/mm³  who are initiating therapy with stavudine, lamivudine

DMP 266-006

Multizentrische, randomisierte, offene Phase III-Studie zum Vergleich der antiretroviralen Aktivität und Verträglichkeit drei verschiedener Kombinationstherapien bei HIV-infizierten Patienten (DMP-266 plus Indinavir, DMP-266 plus Zidovudin plus Lamivudin, Indinavir plus Zidovudin plus Lamivudin

DMP 266-027

Eine offene, randomisierte, multizentrische Studie der Phase II bei HIV-1 infizierten Patienten zur Bewertung der Sicherheit und Dauer der Virussuppression unter einer fortgesetzten Standardtherapie bestehend aus einem Protease-Inhibitor und zwei Nukleosidalen Reverse Transkriptase-Inhibitoren im Vergleich zu zwei neuen Therapieschemata, in denen entweder die Nukleosidalen Reverse Transkriptase-Inhibitoren oder der Protease-Inhibitoren durch DMP 266 ersetzt wird.

MKC-302

A randomized double-blind comparison of MKC-442 versus placebo in antiretroviral-naive patients with HIV-1 RNA >5000 and £300 000 copies/ml and CD4+ >300 cells/mm³ who are initiating therapy with stavudine, didanosine

MKC 502

An open-label extension study for patients on an emivirine containing regimen (roll over protocol for the MKC-301 and 302 being conducted in Europe)

APV 20001

A phase II randomised, multicenter, partially blinded, crossover study to assess the safety, tolerability, pharmacokinetics, and antiviral effect of two doses of GW433908 compared to Amprenavir (1200 mg bid) when given for 28 days to subjects infected with HIV-1

SU 5416.003

A multicenter, dose escalating study in patients with cutaneous AIDS-related Kaposi’s Sarcoma

SU 5416.301

A multicenter, open-Label, phase II study of the efficacy and saftety of SU5416 in patients with therapy refractory cutaneous AIDS-related Kaposi’s Sarcoma

DMP 266-053

Eine multizentrische, offene Phase III Studie zum Vergleich der antiretroviralen Aktivität, Verträglichkeit und Sicherheit von drei verschiedenen Kombinationstherapien bestehend aus: Efavirenz + Stavudine + Didanosin / Abacavir + NRTI + Lamivudin / Stavudin + Didanosin + Indinavir bei HIN-infizierten Patienten. Eine Folgestudie für die Studie DMP 266-006

NNR 20001

GW433908 vs. amprenavir

Switch

Ersatztherapie nach dreifach kombinierter Induktionstherapie zur Verlängerung des Netto-Therapieeffektes durch Verzögerung der Resistenzentwicklung bei HIV-1 infizierten Patienten (multizentrische, randomisierte, open-label Studie).

SILCAAT

A phase III, multicenter, randomized trial on the biological and clinical efficacy of subcutaneous, recombinant human Interleukin-2 in HIV infected patients with low CD4+ count by active, antiretroviral therapy 2000

Great Study

A randomized international, parallel group, open label comparison of the efficacy of second line antiretroviral therapy chosen based on best clinical judgment, or best clinical judgment plus HIV resistence genotyping supported by HIV Resistance Support Software interpretation, in HIV infected patients failing their first protease containing regime.

GF 9037 (Serostim)

A randomized, parallel group, double-blind, placebo-controlled, dose-ranging, multicenter study of recombinant human growth hormone (Serostim) in the treatment of HIV associated catabolism/wasting

DPC 083-201

A phase II, randomized, double-blind, dose-ranging study to assess the safety and tolerability of three doses of DPC 083 versus Efavirenz, in combination with open-label Zidovudine and Lamivudine, in antiretroviral-naive, HIV-1-infected subjects

GS-99-903 (Tenofovir)

A phase III randomized, double-blind, multicenter study of the treatment of antiretroviral-naive, HIV-1-infected patients comparing with Lamivudine and Efavirenz versus Stavudine, Lamivudine and Efavirenz

Saquinavir Pharmakokinetik

Comparative pharmacokinetics of twice-daily saquinavir administered as the soft gel capsule formulation or the hard gel capsule formulation in combination with ritonavir

APV 30002

A randomized, open label two arm trial to compare the safety und antiviral efficacy of GW 433908/Ritonavir to Nelfinavir BID when used in combination with Abacavir and Lamivudine BID for 48 weeks in antiretroviral therapy naive HIV-1 infected subjects

FTC-301

A randomized, double-blind, equivalence trial comparing Emtricitabine to Stavudine with a triple drug combination containing Didanosine plus Efavirenz in antiretroviral drug naive HIV-1 infected patients 2001

TORO 1 / TORO 2   RO 29-9800 T20-302/BV 16052

A phase III open-label, randomized, active, controlled study assessing the efficacy and saftey of T20 / Ro 29-9800 (HIV-1 fusion inhibitor) in combination with an optimized background regimen, versus optimized background regimen alone, in patients with prior experience and/or prior documented resistance to each of the three classes of approved antiretrovirals (nucleoside reverse transciptase inhibitors, non-nucleosids reverse transcriptase inhibitors and protease inhibitors)

BI 1182.6 (Tipranavir)

A phase IIa open-label multinational study of the effects of three dose pairs of Tipranavir/Ritonavir (b.i.d.) on the pharmacokinetic characteristics of protocol-defined, baseline, triple drug nucleoside and non-nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected subjects.

DPC 083-203

A Phase II randomized, double-blind, multicenter study to assess the safety and efficacy of two doses of  DPC 083, in combination with open-label Nucleoside Analog Reverse Transcriptase Inhibitors in HIV-1–infected subjects who are failing treatment with a non-nucleoside reverse transcriptase inhibitor-containing regimen

APV 30003

A phase III, randomized, multicenter, parallel group, open-label, three arm study to compare the efficacy and safety of two dosing regimes of GW433908/Ritonovir (700mg/100 mg twice daily or 1400mg/200mg once daily) versus Lopinavir/Ritonavir (400mg/100mg twice daily) for 48 weeks in protease inhibitor experienced HIV-infected Adults experiencing virological failure

CNA 30021 (Zodiac)

A phase III, 48-week, randomised, double-blind, multicenter study to evaluate the safety and efficacy of Abacavir 600 mg once-daily (QD) vs. Abacavir 300 mg BID in combination with Lamivudine 300 mg QD and Efavirenz 600 mg QD in antiretroviral therapy naive HIV-1 infected subjects

TMC125-C207

Efficacy of an 8-day treatment (7 days b.i.d. and 1 day o.d.) with 900mg TMC125 in HIV-1 positive subjects with phenotypically confirmed NNRTI resistance

GS-00-951 (Tenofovir EAP)

Eine offene Phase IIIb Studie zur Sicherheit und Verträglichkeit von Tenovovir Disoproxil Fumarat bei der Behandlung von HIV-infizierten Patienten mit begrenzten Behandlungsmöglichkeiten

BI 1100. 1359

Investigation of pharmacokinetic interaction of nevirapine and Methadon in HIV-infected patients under combination treatment with various NRTIs, phase IV

TMC114-C201

A phase IIa open, randomized trial to determine the antiviral activity in 60 HIV positive subjects with multiple PI resistant strains, receiving either control treatment or a daily dose of 800, 1600, 2400 or 3600 mg for 13 days followed by a single dose on day 14

AXDC-1(AXD455)

A phase-IIa repeat dose-rising study to explore the safety, efficacy and pharmakokinetics of intravenous AXD 455 doses in HIV-infected patients with multi-resistance or intolerable side effects on haart

DPC 083-303

A Phase III, randomized, double-blind, multicenter study to acess the safety and   efficacy of DPC 083 versus Nelfinavir in combination with AZT/3TC (i.e. Zidovudine and Lamivudine) in antiretroviral-naive HIV‑1‑infected subjects

TMC125-C203/ C209

A randomized, placebo-controlled phase II trial in HIV-1 infected, NRTI-, PI- and NNRTI-experienced subjects to evaluate the safety, tolerability and efficacy of different doses of TMC125 b.i.d. on top of an individually optimized antiretroviral therapy by means of a 3-stage dose-escalating design 2002

BI 1182.52 (Tipranavir)

A phase IIb double-blind, randomized, dose optimization trial of three doses of Tipranavir boosted with low dose Ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects.

TMC114-C207

A phase IIa open, randomized trial to determine the antiviral activity in HIV-1 positive subjects with multiple PI resistant strains, receiving either control treatment or TMC 114/Ritonavir treatment at various dosages for 13 days followed by a single dose on day 14

P00738-65 (PEG-Intron)

Klinische Prüfung der Phase 3 zu PEG-Intron bei intensiv behandelten HIV infizierten Patienten

CI-PSI-004-02-101 (Racivir)

A phase I study exploring the safety, tolerability, pharmacokinetics and virological effect of RCV after 14 days of oral ascending doses of 200, 400 and 600 mg RCV when used in combination with Efavirenz and Stavudine in HIV-infected men

APV 30005

An open-label phase III study to assess the long term safety profile of GW33908 containing regimens in HIV-1 infectect subjects

BI 1182.48 (RESIST-2)

Randomized, open-label, comparative safety and efficacy study of Tipranavir boosted with low-dose Ritonavir versus genotypically-defined Protease Inhibitor/Ritonavir in multiple antiretroviral drug-experienced patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir) 2003

BI 1182.17

A long-term open-label roll-over trial assessing the safety and tolerability of combination Tipranavir and Ritonavir use in HIV- infected subjects

BI 1182.51

An open label, randomized, parallel group pharmacokinetics trial of tipranavir / ritonavir (TPV/TRV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced patients

Kinesa

Simultaneous boosting of Nelfinavir and Saquinavir by small doses of Ritonavir: a pharmakokinetic study in HIV-infected patients

TMC114-C213

A phase II randomized, controlled (standard of care), partially blinded, 48-week trial to investigate dose response of TMC114/rtv in 3-class-experienced HIV-infected subjects 2004

TMC114-C215

An open-label trial of TMC114/rtv in HIV-1 infected, treatment experienced subjects

BI 1182.33

A phase IIb/III randomised, open label, active controlled trial to evaluate the antiviral efficacy and safety of treatment with 500 mg Tipranavir plus 100 mg or 200 mg Ritonavir p.o. BID in combination with standard background regimen in comparison to 400 mg Lopinavir plus 100 mg Ritonavir p.o. BID in combination with standard background regimen in antiretroviral therapy naïve patients for 48 weeks

INCB 8721 RVT-203 (Reverset)

A phase II placebo-controlled, double-blind, parallel dose group study exploring the safety, tolerability and virological effect of 50, 100 and 200 mg RVT in HIV-infected antiretroviral therapy-experienced subjects when used in combination with other antiretroviral agents

R27874-C202

A phase II, proof of principle, randomized, open-label trial in HIV-infected subjects with NNRTI experience and/or genotypic evidence of NNRTI resistance, who will receive R27874 once daily for 7 days in substitution for the NNRTI or PI in failing ART

TMC125-C141

A Phase I ,open-label, randomized, single dose, cross-over study to evaluate the relative bioavailability of 3 dose levels of TMC125 in HIV-1 infected subjects as a spray-dry formulation compared to the reference formulation TF035.

INCB 8721 DFC-901 (Reverset r-o)

A long-term open-label non-randomized study to evaluate the safety of 100 and 200 mg ReversetTM (RVT) in HIV-infected antiretroviral therapy-experienced subjects when used in combination with other antiretroviral agents 2005

A4001028

A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5-antagonist, UK-427,857, in combination with OBT versus OBT alone for the treatment of antiretroviral-experienced HIV-1-infected subjects

A4001029 (Motivate)

A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5-antagonist, UK-427,857, in combination with OBT versus OBT alone for the treatment of antiretroviral-experienced non CCR5-tropic HIV-1-infected subjects

CCR102881 (ASCENT)

A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW 873140 in combination with AZT/3TC (Lamivudine + Zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naïve adults

TMC125-C228

A Phase I randomized, open-label, multiple dose, cross-over trial in HIV-1 infected subjects to evaluate the relative bioavailability of TMC125 as a spray-dry formulation compared to the reference formulation TF035

TMC 278-C204

A phase IIb randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naïve HIV-1 infected subjects. EudraCT No. 2004-004055-19.

TMC114-C208

An open label trial of TMC114/rtv in HIV-1 infected subjects who were randomized in the trials TMC114-C201, -207 or in sponsor selected phase-I-trials

TMC114-C214

A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/RTV versus LPV/RTV in treatment-experienced HIV-1 infected subjects. EudraCT No. 2005-000594-22

TMC125-C229

An open-label trial with TMC125 in HIV-1 infected subjects, who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial and were treated for at least 48 weeks

TMC125-C216 (DUET 2)

A Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options. [IND No. 63646] – A substudy of TMC125-C216 to evaluate the pharmacokinetic profile of TMC125, TMC114 and RTV at Week 4 and 24, co-administered with an individually optimized antiretroviral therapy 2006

TMC125-C217

An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216)

TMC 114-C211 (ARTEMIS)

A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/Ritonavir versus Lopinavir/Ritonavir in treatment-naive HIV-1 infected subjects. This trial will be referred to as ARTEMIS. EudraCT No. 2005-002486-36

AI 424-138 (CASTLE)

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir with Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment Naïve Subjects

BI 1100.1452

A Case-Control Toxicogenomics Study to Identify Genetic Locus or Loci in Patients who have Experienced Symptomatic Hepatotoxicity and Severe Skin Rash within the First 8 weeks of Nevirapine Therapy. EudraCT No. 2005-004321-26

MK-0518-018 (BENCHMARK-1)

A multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of MK-0518 in combination with an optimized background therapy (OBT) versus optimized background therapy alone, in HIV Infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies. 
 EudraCT No. 2005-005127-34.

BI 1100.1470 (ARTEN)

Open-label, randomised clinical trial to compare the virological efficacy and safety of Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine vs. Nevirapine on same background, in HIV-1-infected patients who have received no previous antiretroviral treatment. EudraCT No. 2005-004330-40.

MK-0518 032-00

A randomized, double blind, two-armed trial to evaluate the efficacy and safety of MK-0518 versus LPV/RTV in patients with maximum suppression with LPV/RTV 2007

BI 1100.1498 (ERVIR)

Steady State Bioavailability of 2 different Viramune Extended Release formulations compared to steady state 400 mg of Viramune (200 mg BID) in HIV infected subjects, an open label, non randomized, multidose and multistage parallel group study.

ACH443-014A

A 14-Day, Randomized, Double-blind, comparative viral kinetic study of  Elvucitabine  versus Lamivudine administered  once daily to HIV-1 infected subjects with a documented M184V variant

ACH443-018

An open-label, 24-week extension study of Elvucitabine administered in combination with background antiretroviral agents in subjects who have completed 14 days of treatment in protocol ACH443-014A 2008

BI 1182.107

A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and Safety in HIV-1 positive treatment naïve patients

BI 1100.1486 (Verxve)

A randomised, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400 mg QD Nevirapine extended release formulation in comparison to 200 mg BID antiretroviral therapy naïve HIV-1 infected patients. EudraCT No. 2007-003654-29.

BI 1241.2

Safety, antiviral activity and pharmacokinetics of multiple oral doses of BI 207127 NA administered q8H for 5 days as monotherapy: a randomised, double-blind, placebo controlled study. 
 EudraCT No. 2007-004068-38.

AVX-301

A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of Apricitabine versus Lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase. EudraCT No. 2007-003281-18.

TMC 278-TiDP6-C215 (Thrive)

A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus Efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects. EudraCT No. 2007-002647-25.

BI 1100.1526 (Tranxition)

An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400 mg QD or remaining on Nevirapine IR 200 mg BID based regimen. EudraCT No. 2008-004681-55.

BI 1220.5

Antiviral effect, safety and pharmacokinetics of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 24 weeks as combination therapy with pegylated interferon-α 2a and ribavirin (double-blinded, randomised, placebo-controlled, Phase II). EudraCT No. 2008-003538-11.

112353 (TH-HIV-010 PRI)

A Phase I, randomised, placebo controlled, observer blind, multicentre study to determine safety and reactogenicity of F4co/AS01B vaccine, administered intramuscularly according to a 0, 1 Month schedule in HIV-infected subjects aged 18-55 years. EudraCT No. 2008-005009-20. 2009

CT-BI Vacc-4x 2007/1

A Phase II, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ART. 
 EudraCT No. 2007-006302-13.

A4001078

Pilot Study of  novel Combination of Maraviroc + Atazanavir/Ritonavir vs Atazanavir/Ritonavir + Tenofovir/Emtrici- tabine for the treatment of Treatment naive HIV-infected patients with R5 HIV-1. EudraCT No. 2008-007038-24.

TMC 310911-TiDP-21-C201

A Phase IIa, open-label, randomized trial in treatment-naive HIV-1-infected subjects to determine the antiviral activity of 14 days of monotherapy with 2 different b.i.d. dose regimens of TMC310911 co-administered with ritonavir. EudraCT No. 2008-008190-58

MK-7009

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection. 
 EudraCT No. 2008-000150-12.

BI 1241.7

Safety, antiviral activity, and pharmacokinetics of BI 207127 NA administered in combination with Peg-IFN and ribavirin in chronic HCV infected patients for 4 weeks, a randomised, double-blind, placebo controlled study. EudraCT No. 2008-008292-34.

TMC435-TiDP16-C205 (Pillar)

A Phase IIb, randomized double-blind, placepo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve genotype 1 hepatitis C-infected subjects. EudraCT No. 2008-007147-13.

TMC435-TiDP16-C206 (Aspire)

A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNα-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNα-2a/b and RBV therapy. EudraCT No. 2009-010590-20.

START

Strategic Timing of AntiRetroviral Treatment (START) to determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause. EudraCT No. 2008-006439-12

BI 1241.21 (SOUND)

Safety, antiviral effect and pharmacokinetics of BI 207127 incombination with BI 201335 and with ribavirin for 4 (Part 1) and with or without ribavirin for 24-48 weeks (Part 2) in patients with chronic HCV genotype 1 infection (randomized, open label, Phase II). EudraCT No. 2009-018197-66

A8121014 (Fitness)

(Filibuvir in Treatment Naïve HCV Genotype 1 Subjects) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Filibuvir Plus Pegylated Interferon Alfa-2a and Ribavirin in Treatment naïve, HCV Genotype 1 Infected Subjects. EudraCT No. 2009-009214-40 2010

GS-US-216-0114

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No. 2009-016759-22

TMC435HPC3002

A prospective 1-year virological follow-up study in subjects previously treted in Phase IIb or Phase III study with a TMC435-containing regimen for the trearment of hepatitis C virus (HCV) infection. 2011

TMC278-TiDP6-C222

An open-label trial with TMC275 25mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide revers transcriptase inhibitors in HIV-1 infected subjects, who partici- pated in TMC278 clinical trials. EudraCT No.: 2010-021209-18

ING114467 (SINGLE)

A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/ lamivudine fixed dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naïve aduld subjects. EudraCT No. 2010-020983-39

GS-US-264-0106 (SPIRIT)

A Phase 3 Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically-Suppressed, HIV-1 Infected Patients.  EudraCT No. 2010-023178-37

BI 1220.30

Efficacy and safety of once daily BI 201335 for 12 or 24 weeks in combination with pegylated interferon-α and ribavirin in treatment naïve patients with genotype 1 chronic hepatitis C infection (double-blinded, randomised, placebo-controlled, Phase III). EudraCT No. 2010-021716-42

BI 1220.7

A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 for 24 weeks in combination with pegylated interferon-α and ribavirin in patients who failed to a prior PegIFN / RBV treatment with genotype 1 chronic hepatitis C infection. EudraCT No.: 2010-021715-17

A4001098

A Multicenter, Randomized, Blinded, Placebo-Controled Study to evaluate the Safesty of Maraviroc in Combination with other Antiretroviral Agents in HIV-1-Infected Subjects Co-Infected with Hepatitis C and/or Hepatitis B Virus. EudraCT No. 2010-021994-35

BI 1220.48

A phase III, open-label, study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-α and ribavirin in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN / RBV treatment. EudraCT No.: 2011-000347-25

GS-US-264-0110 (STAR)

A Phase 3B, Randomized, Open-label Study to Evaluate theSafety and Efficacy of a Single Tablet Regimen of Emtricitabine/ Rilpivirine/Tenofovir Disoproxil Fumarate Compared with a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No. 2010-024007-27

BI 1220.19

Safety and Efficacy of 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HC V-co-infected patients. A multinational, randomised, parallel group, open-label trial. EudraCT No.: 2010-021734-59

AI438-011

A Phase IIb Randomized, Controlled, Partially Blinded Trial to Investigate Safety, Efficacy and dose-response of BMS-663068 in Treatment-experienced HIV-1Subjects, Followed by an Open-label Period on the Recommended Dose. EudraCT No.: 2011-000437-36

A4001095 (MODERN)

Multizentrische, randomisierte, doppelblinde Vergleichsstudie zu Maraviroc und Darunavir/Ritonavir versus Emtricitabin/ Tenofovir + Darunavir/Ritonavir zur Behandlung nicht antiretroviral vorbehandelter HIV-Patienten mit CCR5-tropem HIV-1. EudraCT No.: 2010-021785-30

TMC647055HPC1005

A Phase I, open label trial in genotype 1 HCV-infected subjects to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir. EudraCT No.: 2011-004028-37 2012

GS-US-236-0115

A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients. 2011-004483-30

AI447-028 (DUAL)

A Phase 3 Study with Asunaprevir and Daclatasavir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligibleto P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection. EudraCT No.:  2011-005446-35

CT-BI Vacc-4x/IMiD-2010/1

Randomized, Double-blind Placebo Controlled, Multicenter, Immunogenicity Pilot Study of Vacc-4x + Revlimid Versus Vacc-4x in Subjects Infected with HIV-1, on Antiretroviral Therapy (ART). EudraCT No.: 2011-001217-13

CT-BI Vacc-4x 2012/1

Re-boosting of Subjects Previously Included in the Phase IIB Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART. EudraCT No. 2012-002281-12

GS-US-236-0121 (STRATEGY)

A Phase 3b Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients  EudraCT No.: 2011-004963-56

MK 1439-007

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK- 1439 Plus TRUVADA Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients. EudraCT No.: 2012-001573-93

BI 1241.30

A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1 chronic hepatitis C infection. EudraCT No. 2012-003534-17 2013

BI 1241.20

A phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 HCV Infection. EudraCT No.: 2012-03533-41

TMC647055HPC2001

A Phase IIa, open-label trial to evaluate the safety, tolerability and efficacy of a 12 weeks combination therapy of TMC647055 and TMC435, with and without GSK2336805, with a pharmacokinetic enhancer with and without ribavirin in chronic genotype 1 hepatitis C infected patients. EudraCT No. 2012-002555-42 2014

MK 0518-292

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir  (MK-0518) 1200 mg Once Daily Versus Raltegravir (MK-0518) 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects. EudraCT No.: 2013-001939-47

ASTRAL-3 GS-US-342-1140

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection. EudraCT-No.2014-001682-27

ASTRAL-1 GS-US-342-1138

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV. EudraCT-No. 2014-001683-35

GS-US-342-1446

An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection.EudraCT-No. 2014-003898-42 2015

MK 3682-011 C-Crest

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT1, GT2, and GT4 Infection. EudraCT-No.: 2014-003304-73

201637 SWORD

A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-,NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed. EudraCT No.: 2014-005148-16

AI468-038

A Phase 2b Randomized, Active-Controlled, Double-blind Trial to Investigate Safety, Efficacy and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults. EudraCT No.: 2013-005487-26

TMC114FD2HTX3001 AMBER

A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/ tenofovir alafenamide once-daily single-tablet regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination combined with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects. EudraCT No.: 2015-000754-38

GS-US-292-1823

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV‑1 Infected Adult Subjects. EudraCT No.: 2015-002711-15

GS-US-380-1878

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults. EudraCT No.: 2015-004011-20

GS-US-380-1844

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed. EudraCT No.: 2015-004025-14

last change: 18-MAR-2019

Current Studies

HPV

V503-049

A Phase 3, International, Multi-center, Randomized, Double-blind, Placebocontrolled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age. EudraCT No.

HBV

73763989HPB2001

A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection – The REEF-1 Study. EudraCT No. 2019-000622-22

HIV

MK-8591A-018

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to MK-8591A Once-Daily in HIV-1-Infected Participants Virologically Suppressed on bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) EudraCT No. 2019-000587-23

FindHIV

Frühzeitige Identifikation mittels normierter Diagnosekriterien für die HIV-Infektion. (dagnä-Studie)

204862 TANGO

A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV 1 infected adults who are virologically suppressed. EudraCT No.:2015-004401-17

207966 ATLAS 2M

A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed. EudraCT No.: 2017-002946-62

201585 ATLAS

A Phase III, randomized, multicenter, parallel-group, noninferiority,open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus longacting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who arevirologically suppressed. EudraCT No.: 2016-001646-25

201584 FLAIR

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants.  EudraCT No.: 2016-001646-25

GS-US-380-1490

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/ Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No.: 2015-003988-10

AI438-047

A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1. EudraCT No.: 2014-002111-41

200056 LATTE-2

A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/ Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects. EudraCT No.: 2013-000783-2

Last change: 07-JUL-2020

Associated Physicians in Private Practice

Dr. Ulrich Bohr
 

Facharzt für Innere Medizin / Gastroenterologie, Infektiologie, Suchtmedizinische Grundversorgung

  Praxiszentrum Kaiserdamm, Kaiserdamm 24, 14057 Berlin, Fon 030  301 13 90 www.praxiszentrum-kaiserdamm.de
Dr. Christiane Cordes
  Fachärztin für Allgemeinmedizin / Infektiologie (DGI)  

Warschauer Str. 33, 10243 Berlin,
Fon 030 97 00 22 88 www.drcordes.de

Klaus Fischer
  Facharzt für Innere Medizin   Wilmersdorfer Str. 62, 10627 Berlin, 
Fon 030 892 94 88 www.schranzundfischer.de
Matthias Freiwald
  Facharzt für Allgemeinmedizin   Ärztezentrum Nollendorfplatz, Nollendorfplatz 3-4, 10777 Berlin, Fon 030 219 676 50 www.aerztezentrum-nollendorfplatz.de
Dr. Tobias Glaunsinger
  Facharzt für Allgemeinmedizin, Infektiologe (DGI und ÄK Berlin)    Praxis Prenzlauer Berg, Danziger Str. 78 b,
10405 Berlin, Fon 030 440 399 72
www.praxis-prenzlauer-berg.de
 Dr. Roland Grimm
   Facharzt für Allgemeinmedizin   Schwerpunktpraxis Mitte, Linienstr. 127, 10115 Berlin, Fon 030 282 50 52 www.spp-mitte.de
Dr. Heribert Hillenbrand
  Facharzt für Innere Medizin, Infektiologe (DGI)   PraxisCityOst – Medizinisches Versorgungszentrum Berlin- Friedrichshain, Gubener Str. 37, 10243 Berlin,
Fon 030 293 639 50 www.praxiscityost.de
Dr. Arne Jessen
  Facharzt für Allgemeinmedizin / Infektiologie (DGI)   Motzstr. 19, 10777 Berlin, Fon 030 235 10 70 www.praxis-jessen.de
Dr. Heiko Karcher
  Facharzt für Innere Medizin und Infektiologie (DGI)   PraxisCityOst – Medizinisches Versorgungszentrum Berlin- Friedrichshain, Gubener Str. 37, 10243 Berlin,
Fon 030 293 639 50 www.praxiscityost.de
Dr. Gerd Klausen
  Facharzt für Allgemeinmedizin   Linienstr. 127, 10115 Berlin, Fon 030 282 50 52 http://www.spp-mitte.de
Siegfried Köppe
  Facharzt für Innere Medizin / Infektiologie (DGI)   Mehringdamm 50, 10961 Berlin,
Fon 030 789 926 35 www.m-50.de
Peter Kreckel
  Facharzt für Innere Medizin   Mehringdamm 50, 10961 Berlin,
Fon 030 789 926 35 www.m-50.de
Dr. Ingo Ochlast
  Facharzt für Allgemeinmedizin und Arbeitsmedizin   Praxisteam Friedrichshain, Petersburger Str. 94, 10247 Berlin, Fon 030 420 82 47 70 www.praxisteam-friedrichshain.de
Dr. Michael Rausch
  Facharzt für Innere Medizin / Infektiologie (DGI)   Ärztezentrum Nollendorfplatz, Nollendorfplatz 3-4, 10777 Berlin, Fon 030 219 676 50 www.aerztezentrum-nollendorfplatz.de
Dietmar Schranz
  Facharzt für Innere Medizin / Infektiologie   WilmersdorferStr. 62, 10627 Berlin,
Fon 030 892 94 88 www.schranzundfischer.de
Dr. Christoph Schuler
 

Facharzt für Allgemeinmedizin / Infektiologe

 

Praxisgemeinschaft Turmstraße, Turmstr. 76A, 10551 Berlin, Fon 030 391 10 21 www.praxis-turmstrasse.de

Kevin Ummard-Berger
 

Facharzt für Allgemeinmedizin

 

UBN/Praxis, Hubertusallee 16, 14193 Berlin, Fon 030 767333 715 http://www.ubn-praxis.de

Thomas Wicke
  Facharzt für Allgemeinmedizin   Novopraxis Berlin, Mohrenstraße 6, 10117 Berlin, Fon 030 34620300 www.novopraxis.Berlin

 

Central Unit Team

Kathleen Puschkasch,

senior study-coordinator and team-manager, joined EPIMED in the year 2002 after having gathered 6 years of experience in home-care AIDS-nursing and counselling. She is responsible for the general workflow management in the study conduct, for the adherence to the EPIMED standard operating procedures, for quality control and for instructing new team members. She is the contact person for the sponsors and for the colleagues in the peripheral units.

Dr. Christina Engelhard,

investigator, specialist for internal medicine joined the EPIMED-team in January 2019. Before she worked as an assistant physician at Helios Klinikum Berlin Buch in the fields of onco-hematology and tumor-immunology, transplantation of stem cells and at the intensive care unit. In close cooperation with the principal investigator Dr. Keikawus Arastéh she reviews new study protocols and controls source data. Furthermore, she is the medical contact person of the private practitioners and sponsors and CROs. She conducts informed consent process with patients, sees patients for screening visits and evaluates laboratory reports and SUA-reports.

Michael Rittweger,

MD, specialist for internal medicine, back-up to the investigator, joined EPIMED in 2004. Besi des working as private practitioner at praxiswilmersdorfer, Berlin he has conducted and attended various clinical studies intra- and extra- company.

Dr. rer. nat. Susan-Beatrice Franz

is as a study-coordinator part of our team since September 2017. After graduating in biology she became a state approved nurse an latest worked as a study-nurse in the Charité – urological unit. She is responsible for the visit planning for several studies, for creating of worksheets, for the shipment logistic of laboratory samples and study drugs, for visit documentation as well as recording and maintaining the study data.

Meltema Friedrich

is working as a study-coordinator at EPIMED since march 2020. She is a state approved nurse and was in charge for clinical studies at the clinic for gynecology at Charité Berlin, Campus Virchow. She is responsible for the visit planning for several studies, for creating of worksheets, for the shipment logistic of laboratory samples and study drugs, for visit documentation as well as recording and maintaining the study data.

Bastian Krondorfer

is in charge of finance and legal at EPIMED since November 2002. He is responsible for the administration of the company as well as for the budget planning of the trials. He is reviewing the offers of the sponsors and he is in charge for the approval records of the ethic advisory boards. He is controlling the company’s data-protection. Additionally he coordinates the public relations and serves as webmaster of www.epimed.org.

Dietmar Schranz,

MD, is since 1999 Chief Executive Officer of EPIMED GmbH. As HIV specialist in private practice in Berlin-Charlottenburg he has been involved in the EPIMED studies from the very beginning.  His executive functions include the review of study offers in regard to feasibility and tolerability as well as leading of the regular study meetings of the EPIMED investigators.

Priv. Doz. Dr. Keikawus Arastéh,

MD, principal investigator, is together with Dietmar Schranz one of the two Chief Executive Officers of EPIMED GmbH with focus on study acquisition. As principal investigator he bears the responsibility over all trials at EPIMED.  Since 1991 he is conducting studies in the field of HIV/AIDS as well as in adjacent indications. He has published in numerous journals and he is a co-author of the German-Austrian guidelines to antiretroviral treatment of the HIV-Infection.

For Doctors

Dietmar Schranz, internist

Dear fellow physician,

Are you a doctor in a private practice resident in the Greater Berlin area, treat patients diagnosed with HIV/hepatitides and other internistic/infectiological fields i.e. STI/novel vaccinations and are interested in participating in clinical studies? Either because you require new therapy options for your patients or because you consider clinical research to be necessary or interesting?

As a regional study site with more than 20 years of experience, we can offer the necessary knowhow and infrastructure. We maintain successful cooperations with major pharmaceutical manufacturers as well as with many independent research institutes, and cover the entire bandwidth of clinical studies from first-rate patient care to the presentation of study findings at scientific conferences.

EPIMED cherish the communication between investigators at one hand and specialists in private practices for the benefit of the patient. Our periodic meetings not only provide information on new studies, but also serve as a venue for discussing the pros and cons of new substances. If you are interested in a cooperation with EPIMED, please do not hesitate to get in touch with us.

Please visit our website for further information on the full spectrum of our activities by clicking on the menu items Studies, About Us and For Sponsors.

Dietmar Schranz

Last change: 02/21/2018

Co-Authorship in Publications (extract)

The Role of Abacavir (ABC, 1592) in Antiretroviral Therapy-Experienced Patients: Preliminary 48-Week Results from a Randomized Double-Blind Trial. Katlama C, Clotet B,  Plettenberg A, Jost J, Arastéh K, Bernasconi E, Jeantils V, Cutrell A, Purdon S, Stone C, Ait-Khaled M; Interscience Conference on Antimicrobial Agents and Chemotherapy. NCBI PubMed AIDS. 2000 May 5;14(7):781-9.

GW420867X administered to HIV-1-infected patients alone and in combination with lamivudine and zidovudine. K Arasteh, R Wood, M Müller, W Prince, L Cass, KH Moore, N Dallow, A Jones, A Klein, V Burt, JP Kleim. HIV clinical trials 2001 Jul-Aug.

Enfurvirtide in combination with an optimized backgraound regimen vs OB alone: week 24 response among categories of baseline demographics, treatmentexperience, and HIV antiretroviral resistance. J Lange, A Lazzarin, B Clotet, D Cooper, J Reynes, K  Arastéh. Int Cong Drug Therapy Hv 2002 Nov 17-21;6:Abstract No. PL14.3.

An Open-Label Assessment of TMC 125 – A New, Next-Generation NNRTI, for 7 Days in HIV-1 Infected Individuals With NNRTI Resistance. Brian G. Gazzard; Anton L. Pozniak; Willy Rosenbaum; G. Patrick Yeni; Schlomo Staszewski; Keikawus Arastéh; Karin De Dier; Monika Peeters; Brian Woodfall; Justin Stebbing; Gerben A. E. vant’ Klooster. AIDS 17(18):F49-F54, 2003.

Correlation of Viral Load Reduction and Plasma Levels in Multiple Protease Inhibitor Experienced Patients Taking Tipranavir/Ritonavir in a Phase IIB Trial: BI 1182.52. Yeni P, MacGregor T, Gathe J, Arastéh K, Jayaweera D, Jemsek J, Hawkins T, Cameron W, Bodsworth N, McCallister S, Kohlbrenner V, Quinson A, Leith J, Sabo J, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Feb 10 14 2003 Hynes Conv Cent Boston Mass USA Conf Retrovir Oppor Infect 10th 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 528.

Enfuvirtide TORO Studies: 48-Week Results Confirm 24-Week Findings. C. Katlama, K. Arastéh, B. Clotet, D.Cooper, K. Henry, J. Lalezari, A. Lazzarin, J. Montaner, M. Nelson, M. O’Hearn, P. Piliero, J. Reynes, B. Trottier, S. Walmsley, R. DeMasi, J. Delehanty, J. Chung, M. Salgo. 2nd IAS Conference on HIV Pathogenesis and Treatment: Paris, France, July 13-16, 2003

The Effects of Enfuvirtide Therapy on Body Composition and Serum Lipids through 48 Weeks in the TORO Trials. Cooper D, Reiss P, Henry K, Nelson M, O’Hearn M, Piliero P, Reynes J, Arastéh K, Chung J, Guimaraes D, Kinchelow T, Bertasso A; the TORO 1 and TORO 2 study groups; Conference on Retroviruses and Opportunistic Infections (11th : 2004 : San Francisco, Calif.). Program Abstr Conf Retrovir Oppor Infect 11th 2004 San Franc Calif. 2004 Feb 8-11; 11: abstract no. 715

TORO: 96 week virological and immunological response and safety evaluation of enfuvirtide with an optimized background regimen. Arastéh K, Lazzarin A, Clotet B, Lalezari J, Cooper D, Henry K, O’Hearn M, Reynes J, Piliero P, Trottier B, Montaner J, Walmsley S, Nelson M, Katlama C, Chung J, DeMasi R, Guimaraes D, Huson L, Donatacci L, Wat C, Kinchelow T, Bertasso A, Miralles GD, Salgo M. Int Conf AIDS. 2004 Jul 11-16; 15: abstract no. MoOrB1058.

Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. Lazzarin A, Clotet B, Cooper D, Reynes J, Arastéh K, Nelson M, Katlama C, Stellbrink HJ, Delfraissy JF, Lange J, Huson L, DeMasi R, Wat C, Delehanty J, Drobnes C, Salgo M; TORO 2 Study Group. N Engl J Med. 2003 May 29;348(22):2186-95.

Sustained Anti-HIV-1 Effect of Racivir Combined with D4T and Sustiva Following a 14-day Treatment of Infected Volunteers. Otto MJ, Arasteh K, Kreckel P, Drauz D, Beard A, Cartee L, Hurwitz SJ, Liotta DC, Schinazi RF, Murphy RL. Abstr 10th Conf Retrovir Oppor Infect 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 552.

Correlation of Viral Load Reduction and Plasma Levels in Multiple Protease Inhibitor Experienced Patients Taking Tipranavir/Ritonavir in a Phase IIB Trial: BI 1182.52. Yeni P, MacGregor T, Gathe J, Arastéh K, Jayaweera D, Jemsek J, Hawkins T, Cameron W, Bodsworth N, McCallister S, Kohlbrenner V, Quinson A, Leith J, Sabo J, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Feb 10 14 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 528.

Tipranavir/Ritonavir Demonstrates Potent Efficacy in Multiple Protease Inhibitor Experienced Patients: BI 1182.52. Gathe J, Kohlbrenner VM, Pierone G, Arastéh K, Rubio R, LaLonde R, Piliero P, McCallister S, Garfinkel S, Chaves R, Mukwaya GM, Dohnanyi C, Shaw S, Drees U, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Boston Mass. 2003 Feb 10-14; 10: abstract no. 179.

Nevirapine significantly reduces the levels of racemic methadone and (R)-methadone in human immunodeficiency virus-infected patients. Stocker H, Kruse G, Kreckel P, Herzmann C, Arasteh K, Claus J, Jessen H, Cordes C, Hintsche B, Schlote F, Schneider L, Kurowski M. Antimicrobial Agents and Chemotherapy, Nov 2004, p. 4148-4153, Vol. 48, No. 11.

Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients. Wood R, Arastéh K, Stellbrink HJ, Teofilo E, Raffi F, Pollard RB, Eron J, Yeo J, Millard J, Wire MB, Naderer OJ.Antimicrobial Agents and Chemotherapy, Jan 2004, p. 116-23, Vol. 48 No.1.

A 42-Week Open-Label Study to Assess the Pharmacokinetics, Antiretroviral Activity, and Safety of Amprenavir or Amprenavir plus Ritonavir in Combination with Abacavir and Lamivudine for Treatment of HIV-Infected Patients. Robin Wood, Joseph Eron, Keikawus Arastéh,  Eugenio Teofilo, Christian Trepo, Jean-Michel Livrozet, Jane Yeo, Judith Millard, Mary Beth Wire and Odin J. Naderer. Clinical Infectious Diseases 2004;39:591–594.

Safety, Pharmacokinetics, and Efficacy of (+/–)-ß-2′,3′-Dideoxy-5-Fluoro-3′-Thiacytidine with Efavirenz and Stavudine in Antiretroviral-Naïve Human Immunodeficiency Virus-Infected Patients. C. Herzmann, K. Arastéh, R. L. Murphy, H. Schulbin, P. Kreckel, D. Drauz, R. F. Schinazi, A. Beard, L. Cartee, and M. J. Otto.Antimicrobial Agents and Chemotherapy, Jul 2005, p. 2828-33, Vol. 49, No.7.

TMC114/ritonavir substitution for protease inhibitor(s) in a non-suppressive antiretroviral regimen: a 14-day proof-of-principle trial. Arastéh K, Clumeck N, Pozniak A, Lazzarin A, De Meyer S, Muller H, Peeters M, Rinehart A, Lefebvre E; TMC114-C207 Study Team. NCBI PubMed AIDS. 2005 Jun 10;19(9):943-7.

Six-Week Randomized Controlled Trial To Compare the Tolerabilities, Pharmacokinetics, and Antiviral Activities of GW433908 and Amprenavir in Human Immunodeficiency Virus Type 1-Infected Patients.Robin Wood, Keikawus Arastéh, Hans-Jürgen Stellbrink, Eugenio Teofilo, François Raffi, Richard B. Pollard, Joseph Eron, Jane Yeo, Judith Millard, Mary Beth Wire and Odin J. Naderer. Antimicrobial Agents and Chemotherapy Jan 2004, p 116-23, Vol. 48 No. 1.

Safety of Enfuvirtide in Combination With an Optimized Background of Antiretrovirals in Treatment-Experienced HIV-1-Infected Adults Over 48 Weeks. Benoit Trottier, MD; Sharon Walmsley, MD; Jacques Reynes, MD, PhD; Peter Piliero, MD; Mary O’Hearn, MD; Mark Nelson, MA, MBBS, MRCP; Julio Montaner, MD; Adriano Lazzarin, MD; Jacob Lalezari, MD; Christine Katlama, MD; Keith Henry, MD; David Cooper, MD, DSc; Bonaventura Clotet, MD, PhD; Keikawus Arastéh, MD; Jean-François Delfraissy, MD; Hans-Jürgen Stellbrink, MD; Joep Lange, MD, PhD; Daniel Kuritzkes, MD; Joseph J Eron, Jr MD; Calvin Cohen, MD, MSc; Tosca Kinchelow, MD; Anne Bertasso, BS; Emily Labriola-Tompkins, BA; Anna Shikhman, BSN, MBA; Belinda Atkins; Laurence Bourdeau, PhD; Christopher Natale, MSc; Fiona Hughes, BSc; Jain Chung, PhD; Denise Guimaraes, MS; Claude Drobnes, MD; Silvia Bader-Weder, MD; Ralph DeMasi, PhD; Lynn Smiley, MD; Miklos P Salgo, MD, PhD. Journal of Acquired Immune Defic Syndr. 2005;40(4):413-421.

Ritonavir-boosted tipranavir demonstrates superior efficacy to ritonavir-boosted protease inhibitors in treatment-experienced HIV-infected patients: 24-week results of the RESIST-2 trial. Cahn P, Villacian J, Lazzarin A, Katlama C, Grinsztejn B, Arastéh K, López P, Clumeck N, Gerstoft J, Stavrianeas N, Moreno S, Antunes F, Neubacher D, Mayers D. Clin Infect Dis. 2006 Nov 15;43(10):1347-56.

Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial.  Lazzarin A, Campbell T, Clotet B, Johnson M, Katlama C, Moll A, Towner W, Trottier B, Peeters M, Vingerhoets J, de Smedt G, Baeten B, Beets G, Sinha R, Woodfall B; DUET-2 study group. Lancet. 2007 Jul 7; 370(9581):39-48.

Efficacy and Safety of Three Doses of Tipranavir Boosted with Ritonavir in Treatment-ExperiencedHIV Type 1-Infected Patients. Joseph C. Gathe jr, Gerald Pierone, Peter Piliero, Keikawus Arastéh, Rafael Rubio, Richard G. Lalone, David Cooper, Adriano Lazzarin, Veronika M. Kohlbrenner, Catharine Dohnanyi, John Sabo and Douglas Mayers. AIDS Research and Human Retroviruses Vol. 23, No. 2, 2007, pp. 216–223.

Saquinavir, nelfinavir and M8 pharmacokinetics following combined saquinavir, ritonavir and nelfinavir administration. Stocker H, Herzmann C, Breske A, Kruse G, Berger M, Schulbin H, Hill A, Steinmüller J, Becker M, Arastéh K, Kurowski M. Journal of Antimicrobial Chemotherapy 2007; 59:560-4.

Pharmacokinetics, safety, and efficacy of tipranavir boosted with ritonavir alone or in combination with other boosted protease inhibitors as part of optimized combination antiretroviral therapy in highly treatment-experienced patients (BI Study 1182.51). Walmsley SL, Katlama C, Lazzarin A, Arestéh K, Pierone G, Blick G, Johnson M, Meier U, MacGregor TR, Leith JG. Journal of Acquirerd Immune Defic Syndr. 2008 Apr 1;47(4):429-40.

Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT). K. Arastéh, L. Weitner, S. Fenske, B. Kuhlmann, M. Freiwald, R. Ebrahimi, L. Gallo, B. Ranneberg, T. Mertenskoetter. Eur J Med Res (2009) 14:195-199.

Short-term randomized proof-of-principle trial of TMC278 in patients with HIV type-1 who have previously failed antiretroviral therapy. Keikawus Arastéh, Armin Rieger, Patrick Yeni, Anton Pozniak, Griet Boogaerts, Rolf van Heeswijk, Marie-Pierre P de Béthune, Monika Peeters, and Brian Woodfall. Antiviral Therapy 14(5):713 (2009) PMID 19704175

Prospective comparison of nevirapine and atazanavir/ritonavir both combined with tenofovir DF/ emtricitabine in treatment-naïve HIV-1 infected patients: ARTEN study week 48 results. V. Soriano, S. Köppe, H. Mingrone, T. Lutz, M. Opravil, J. Andrade-Villanuev. Lutz, M. Opravil, J. Andrade-Villanueva, F. Antunes, G. Di Perri, D. Podzamczer, S. Taylor, A. Horban, D. Duiculescu, L. de Rossi. Poster, 5th IAS Conference 2009

ASSESSMENT OF THE STEADY STATE PK PARAMETERS OF TWO EXTENDED RELEASE (XR) NEVIRAPINE (NVP) TABLETS 400 MG AND 300 MG QD COMPARED WITH IMMEDIATE RELEASE (IR) NVP TABLETS 200 MG BID IN HIV-1 INFECTED PATIENTS – THE ERVIR STUDY M. Battegay, K. Arasteh, A. Plettenberg, J. Bogner, N. Brockmeyer, O. Degen, F. Boue, J.M. Livrozet, E. Van-Steenberge, C.L. Yong1, J. Wu, F.J. Mensa, L. Waldhauser, J. Steffgen, F. Berger, J. Stern, P. Robinson, A.M. Quinson. 49th ICAAC, San Francisco, USA,

48 Wk Efficacy and Safety of Switching Virologically Stable HIV-1 Patients from Nevirapine IR 200 mg BID to Nevirapine XR 400 mg QD (TRANxITION)  K. ARASTEH, D. WARD, A. PLETTENBERG, JM. LIVROZET, A. WINSTON, C. CORDES, E. WANG, A. QUINSON. 10th International Congress on Drug Therapy in HIV Infection, Glasgow, November 7-11, 2010

Twenty-four-week efficacy and safety of switching virologically suppressed HIV-1-infected patients from nevirapine immediate release 200 mg twice daily to nevirapine extended release 400 mg once daily (TRANxITION). Arasteh K, Ward D, Plettenberg A, Livrozet JM, Orkin C, Cordes C, Guo J, Wang E, Yong CL, Robinson P, Quinson A. HIV Med. 2012 Apr;13(4):236-44. doi: 10.1111/j.1468-1293.2011.00969.x. Epub 2011 Dec

Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection. Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Müllhaupt B, Gane E, Schuch- mann M, Lohse A, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Kukolj G, Nehmiz G, Haefner C, Boecher WO. Gastroenterology. 2011 Dec;141(6):2047-55; quiz e14. Epub 2011 Sep 16.

4 week therapy with the non-nucleosidic polymerase inhibitor BI 207127 in combination with peginterferon-alfa2A and ribavirin in treatment naïve and treatment experienced chronic HCV GT1 patients. Dominique Larrey, Ansgar Lohse, Victor de Ledinghen, Christian Trepo, Tilman Gerlach, Jean-Pierre Zarski, Albert Tran, Philippe Mathurin, Robert Thimme, Keikawus Arastéh, Christian Trautwein,  Andreas Cerny, Nektarios Dikopoulos, Marcus Schuch- mann, Markus H. Heim, Guido Gerken, Jerry Stern, Katherine Wu, Nasri Abdallah, Birgit Girlich, Joseph Scherer, Wulf Boecher, Frank Berger, Jürgen Steffgen. Gastroenterology. 2011 Dec;141(6):2047-55; quiz e14. Epub 2011 Sep 16.

The SOUND-C1 study: High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI201335, polymerase inhibitor BI207127, and ribavirin, followed by BI201335 and PegIFN/ribavirin Stefan Zeuzem, Tarik Asselah, Peter Angus, Jean Pierre Zarski, Dominique Larrey, Beat Müllhaupt, Ed Gane, Marcus Schuchmann, Ansgar Lohse, Stanislas Pol, Joseph Moussalli, Jean-P. Bronowicki, Stuart Roberts, Keikawus Arasteh, Fabien Zoulim, Jerry O. Stern, Federico Mensa, Gerhard Nehmiz, Carla Häfner, Wulf Otto Böcher. Poster, International Conference on Viral Hepatitis, March 26-27 2012

TRANxITION 144-week results: switching virologically stable HIV patients from immediate-release nevirapine (NVP IR) to extended-release NVP (XR) K Arastéh, M Drulak, J Guo, J Livrozet, C Orkin, A Quinson, D Ward. Journal of the International AIDS Society 2012, 15 (Suppl 4):183

Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. Hodder S, Arasteh K, De Wet J, Gathe J, Gold J, Kumar P, Mohapi L, Short W, Crauwels H, Vanveggel S, Boven K. HIV Med. 2012 Aug;13(7):406-15. doi: 10.1111/j.1468-1293.2012.00991.x. Epub 2012 Mar 14.

Dolutegravir Treatment Response and Safety by Key Subgroups in Treatment Naive HIV Infected Individuals. Cynthia Brinson, Sharon Walmsley, Keikawus Arasteh, Miguel Gorgolas, Lothar Schneider, Clare Brennan, Keith Pappa, Steve Almond, Catherine Granier, Francois Raffi. 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA

STARTVerso 4: High rates of early virologic response in HCV genotype 1/HIV-coinfected patients treated with faldaprevir plus PegIFN and RBV Douglas Dieterich, Vicente Soriano, 2 Mark Nelson, Jürgen Kurt Rockstroh, Keikawus Arastéh, Sanjay Bhagani,Andrew Talal, Cristina Tural, Richard Vinisko, and Jens Kort, 20th Conference on Retroviruses and Opportunistic Infections, March 3–6, 2013

Cobicistat Versus Ritonavir as a Pharmacoenhancer of Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV Type 1–Infected Patients: Week 48 Results Joel E. Gallant,  Ellen Koenig,  Jaime Andrade-Villanueva, Ploenchan Chetchotisakd6, Edwin DeJesus, Francisco Antunes, Keikawus Arastéh, Graeme Moyle, Giuliano Rizzardini, Jan Fehr, Yapei Liu, Lijie Zhong, Christian Callebaut, Javier Szwarcberg, Martin S. Rhee and Andrew K. Cheng, Journal of Infectious Diseases 208(1):32-39. July 1, 2013

STARTVerso 3: A randomized, double-blind, placebo-controlled Phase III trial of faldaprevir in combination with pegylated interferon alfa-2a and ribavirin in treatment-experienced patients with chronic hepatitis C genotype-1 infection Jacobson, Asselah, Ferenci, Foster, Jensen, Negro, Mantry, Wright, Forns, Garcia-Samaniego, Oliveira, Carvalho, Forton, Arastéh, Cooper, Ghesquiere, Dufour, Sakai, Tanaka, Stern, Sha, Boecher, Steinmann, Quinson, on behalf of the STARTVerso3 Study Group, American Association for the Study of the Liver: The Liver Meeting 2013. Poster Number 1100

STARTVerso 4 Phase III Trial of Faldaprevir Once-daily Plus Peg Interferon Alfa-2a and Ribavirin (PR) in Patients with HIV and HCV Genotype 1 Coinfection: End of Treatment Response (ETR) Jürgen Kurt Rockstroh, Mark Nelson, Vicente Soriano, Keikawus Arastéh, Josep Guardiola, Sanjay Bhagani, Josep Mallolas, Cristina Tural, Massimo Puoti, Patrick Ingiliz, Manuel Battega, Mamta K. Jain, Marina Nunez, Kristen Marks, Jens Kort, Jerry Stern, Richard Vinisko, Montserrat Manero, Douglas Dieterich, 14th European AIDS Conference (EACS), 16.-19. October 2013

TRANxITION 144 Week Results: Switching Virologically Stable HIV Patients From Immediate-Release Nevirapine (NVP IR) to Extended-Release NVP (XR) Keikawus Arasteh, Murray Drulak, Junhai Guo, Jean-Michel Livrozet, Chloe Orkin, Ann-Marie Quinson and Douglas Ward, J AIDS Clin Res 2014, 5:4

Antiviral Activity, Pharmacokinetics, and Safety of the HIV-1 Protease Inhibitor TMC310911, Coadministered With Ritonavir, in Treatment-Naive HIV-1–Infected Patients Stellbrink, Hans-Jürgen; Arastéh, Keikawus; Schürmann, Dirk; Stephan, Christoph; Dierynck, Inge; Smyej, Ilham; Hoetelmans, Richard M. W.; Truyers, Carla; Meyvisch, Paul ; Jacquemyn, Bert; Mariën, Kris; Simmen, Kenneth; Verloes, René;  JAIDS Journal of Acquired Immune Deficiency Syndromes:1 March 2014 – Volume 65 – Issue 3 – p 283–289

Faldaprevir Plus Pegylated Interferon α-2a/Ribavirin in HIV/HCV Co‑infection: STARTVerso4 Douglas Dieterich, Cristina Tural, Mark Nelson, Keikawus Arastéh, Vicente Soriano, Josep Guardiola, Sanjay Bhagani, Jürgen K Rockstroh, Jerry O Stern, Anne-Marie Quinson, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

Effect of Faldaprevir on Atazanavir Pharmacokinetics in Patients with HIV/HCV Co-Infection Mark Nelson, Keikawus Arastéh, Mamta K Jain, Vicente Soriano, José Valdez Madruga, Juvencio Furtado, Manuel Battegay, Fenglei Huang, Montserrat Manero, Douglas Dieterich, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

Safety and Antiviral Effect of MK-1439, a Novel NNRTI, (+Truvada®) in ART-Naive HIV Infected Patients J. O. Morales-Ramirez, J. M. Gatell, D. P. Hagins, M. Thompson, K. Arasteh, C. Hoffmann, C. Harvey, X. Xu, H. Teppler, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

SIMILAR ADJUSTED SVR12 RATES FOR HIV CO-INFECTED AND HCV MONO-INFECTED PATIENTS AND NO DOSE OR POPULATION (TREATMENT-NAÏVE/RELAPSER) EFFECT: POOLED ANALYSIS OF FALDAPREVIR PHASE III TRIALS Douglas Dieterich, Peter Ferenci, Ira M Jacobson, Francesco Negro, Massimo Puoti, Jürgen K Rockstroh, Michael P Manns, Keikawus Arastéh, Célia Oliveira, Jean-François Dufour, Elmar Zehnter, Clifford Leen, Sanjay Bhagani, Jerry O Stern, Anne-Marie Quinson, Joseph Scherer, Montserrat Manero, Donald M Jensen,  49th Annual Meeting of the European Association for the Study of the Liver (EASL), April 9–13, 2014

Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: A randomised placebo-controlled study Thomas Harrer, Andreas Plettenberg, Keikawus Arastéh, Jan Van Lunzen, Gerd Fätkenheuer, Hans Jaeger, Michel Janssens Wivine Burny, Alix Collard, François Roman, Alfred Loeliger, Marguerite Koutsoukos, Patricia Bourguignon, Ludo Lavreys, Gerald Voss. Vaccine,Volume 32, Issue 22, 7 May 2014, Pages 2657-2665

Simplification to Stribild vs Continuation of RTV-boosted DRV with FTC and TDF in Virologically Suppressed HIV Adults: A STRATEGY-PI Subgroup Analysis J Arribas, G Rizzardini, K Arastéh, C Zurawski, C Dietz, D Pontani, W Garner, and T Nguyen P273 HIV Drug Therapy, Nov 2-6 2014, Glasgow

Simplification to the STRIBILD single tablet regimen from PI plus RTV plus FTC/TDF multi-pill regimens maintains durable HIV suppression: Week 96 results of STRATEGY-PI (Study 115) K. Arastéh, H.J. Stellbrink, J.K. Rockstroh, A. Rieger, J. Arribas, E. DeJesus, C. Zurawski, M. Doroana, W. Towner, A. Lazzarin, M. Nelson, C. Müller, D. McColl, R. Swamy, T. Nguyen DÖAK 2015 24-27. Juni 2015, Düsseldorf, Germany

Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naive HIV-infected individuals in three randomized Trials. Raffi F, Rachlis A, Brinson C, Arasteh K, Górgolas M, Brennan C, Pappa K, Almond S, Granier C, Nichols WG, Cuffe RL, Eron J Jr, Walmsley S. AIDS. 2015 Jan 14;29(2):167-74.

Efficacy and Safety of Doravirine 100mg qd with TDF/FTC after 24 Weeks of Treatment in ART-Naive HIV-Infected Patients Jose M. Gatell, Francois Raffi, Andreas Plettenberg, Don Smith, Joaquin Portilla Sogorb, Christian Hoffmann, Keikawus Arasteh, Melanie Thompson, Debbie P. Hagins, Javier O. Morales-Ramirez, Xia Xu, Hedy Teppler.  AIDS 2015, Vancouver BC

Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection Stefan Bourgeois*, Hans Van Vlierberghe, Christophe Moreno, Hans Orlent, Frederik Nevens, Keikawus Arastéh, Yves Horsmans, Jörn M Schattenberg, Peter Buggisch, Sven Francque, Leen Vijgen, Thomas N Kakuda, Eva Hoeben, Donghan Luo, An Vandebosch, Bert Jacquemyn, Pieter Van Remoorter, Rene Verloes. Antiviral Therapy 2016

Doravirine 100 mg QD vs Efavirenz +TDF/FTC in ART- Naive HIV+ Patients: Week 48 Results. Jose M. Gatell; Francois Raffi; Andreas Plettenberg; Don Smith; Joaquin Portilla; Christian Hoffmann; Keikawus Arastéh; Melanie Thompson; Xia Xu; Hedy Teppler for the 1439-007 Study Team. Abstract #470 • CROI 2016, Boston MA, USA

Our Partners

Industry

Abbott
Achillion Pharmaceuticals
Ardea Biosciences
Avexa
BionorPharma
Boehringer Ingelheim
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Incyte
Merck Sharp & Dohme
Pfizer
Roche
Janssen
ViiV Healthcare

Contract Research Organisations

Clinical Professionals
ICON Development Solutions
Parexel International
PPD Germany
Quintiles
SGS Medisearch International
CRO – Charité Research Organisation

Research

CHIP – Copenhagen HIV Program
IATEC Clinical Trial Services
INSIGHT- International Network for Strategic Initiatives in Global HIV Trials

Hospital

Vivantes Auguste-Viktoria-Klinikum:
• Clinic for Interior Medicine, Infectiology and Gastroenterology
• Immunologic Day-Clinic

Labs

Covance Central Laboratory Services
Delphic Diagnostic
LabCorp
Labor 28
MDS Pharma Services – Central Lab
PPD Central Lab
Virco
Labor Berlin Charité Vivantes
Quest Diagnostics

Others

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
BIOS3 – IT: Software Systeme, Berlin

Last change: 03/07/2015

Audits

  • Inspection of the BI 1220.7 study by the US Food and Drug Administration (FDA), March/April 2014
  • Audit of the Bionor Vacc-4x IMiD/-2010/1, set by the CRO, Aptiv Solutions, November 2013
  • Audit of the A4001095 study set by the sponsor Pfizer, May 2013.
  • Audit of the GS-US-264-0106 study set by the sponsor Gilead Sciences, November 2011.
  • Audit of the ING114467 study set by the sponsor GlaxoSmithKline, October 2011.
  • Audit of the BI 1100.1486 study set by the sponsor Boehringer Ingelheim, April 2009.
  • GCP-audit (Inspektion) of the BI 1182.107 study by the Landesamt für Gesundheit und Soziales Berlin, June/July 2008.
  • Audit of the AI 424-138 study set by the sponsor Bristol-Myers-Squibb, November 2006.
  • Audit of the WV16789 study, set by the sponsor ROCHE, May 2004.
  • Audit of the BI 1182.52 study set by the sponsor Boehringer Ingelheim, January 2003.
  • GCP-audit of the APV 30005 study set by the sponsor GlaxoSmithKline, October 2002.

Last change: 05/08/2014

Facilities

  • Two state of the art treatment rooms equipped according to all study requirements like physical examinations, ECG recording, blood sampling
  • Eight in-patient beds at disposal for pharmacokinetic trials
  • 24/7 emergency hotline for all participants
  • In-house emergency treatment and intensive care unit at Vivantes Auguste-Viktoria Klinik
  • Direct access to hospital treatment options and medical technology

Lab & Storage

  • Laboratory I equipped with 2 temperature controlled centrifuges, refrigerators (4-8°C), freezers (-40°C and -70°C), dry ice container, well-spaced sample handling and storage area
  • Laboratory II equipped with a biological safety cabinet for PBMC processing, a 3rd temperature controlled centrifuge, a refrigerator (4-8°C) and microscopic technique
  • Secure and temperature-controlled storage for all study medication
  • Secure archive for accurate study recording

Office Extras

  • Three staff offices equipped with WLAN, high performance scanner / print unit, separate high performance FAX
  • Fully equipped conference room with a capacity of 20 persons
  • Separate monitor office with WLAN access and storage space

Last change: 03/07/2016

Welcome

Priv. Doz. Dr. K. Arastéh
Priv. Doz. Dr. K. Arastéh

The success story of EPIMED began in 1997 when it was formed by the Department of Internal Medicine at the Auguste-Viktoria-Klinikum and HIV experts in private practice as a joint site for clinical studies into ART and opportunistic infections. Today EPIMED and its 12 associated practices have more than a decade of experience in conducting phase Ib – IIIb studies, along with investigator-initiated trials, retrospective analyses and pharmacokinetic studies.

While EPIMED started with its initial focus on HIV and HIV-related conditions, we have responded to emerging developments and expanded our expertise into contigous fields of internal medicine and infectioal deseases i.e.hepatitides, vaccinacion studies, STIs.

EPIMED offers an exeptionally high level of cost-effective research and development to our cooperating pharmaceutical companies. The unique structure of our trial site provides us with direct access to approximately 5,000 patients with HIV/AIDS and approximately 1,000 with viral hepatitis, and we are able to maintain the highest standards regarding both quality and quantity when recruiting participants.

In specific cases and when Screening and Baseline are completed at EPIMED central unit in Auguste-Viktoria-Klinikum, the participants in our phase II/III trials may subsequently do their visits in the peripheral units in the associated practices. Our standard operating procedures (SOP) provide detailed guidelines and limitations that regulate everything from screening visits to SAE reporting. These procedures are subject to continuous monitoring and revision in accordance with the requirements of GCP and Germany’s legislation on pharmaceutical trials.

We passed more than 11 audits of clients, local authorities and a FDA-inspection in 2014. The latter concluded, that we adhere all FDA requirements for the counduction of clinical trials and the protection of human subjects. With our well-equipped study site and our extensive experience, we can guarantee data of excellent quality for the research and approval of pharmaceutical products. EPIMED provides an ideal base of dedicated research professionals and participant recruitment with efficient central monitoring.

At EPIMED, patients’ safety and rights are always of central importance to our work.

Fore more information about EPIMED simply contact us by phone or write to us using our contact form. We look forward to hearing from you

Keikawus Arastéh

 

Last change: 02/21/2018

Drug Studies for Patients in the filed of internal medicine/infectiology in Berlin

There is a long way to go until a new drug is ready to be sold in pharmacies. It takes as long as ten years from the first development of a potential remedy to the final approval by the authorities.

 As a matter of fact, EPIMED has been involved in the testing of many of today’s indispensable and well-tolerated  drugs and EPIMED Patients have often the opportunity to be treated with highly effective substances not yet available on the market.

What is a Clinical Study?

The steps of the development of a drug are divided in the pre-clinical (Laboratory, “in vitro”, animal experiments) and in clinical studies.

In the phase I(a) studies a substance will be applied for the first time in humans. These studies are conducted with healthy test persons without the relevant medical condition the drug is developed for to assess the tolerability, the metabolism and the toxicity of a substance. At EPIMED, we do not carry out this phase of trials, yet we do participate in phase I(b) studies. In these clinical trials a drug in development will be studied for the first time in patients bearing the relevant medical condition the drug is being developed for.

Phase II and III studies are research and therapy studies with patients. They are needed to investigate the efficacy, dose finding, development of the pharmaceutical formula, establishing of the side effect profile and the long time tolerability.

Phase IV studies are carried out after the final approval of a drug, e.g. an analysis concerning the long term side effects.

Who Conducts Clinical Studies?

The sponsors are mostly pharmaceutical companies but also national or independent research institutes. Studies are carried out in hospitals and, to a lesser extent, in private practices.

EPIMED is a joint venture of twelve specialists’ practices in the field of internal medicine/infectiology and the Department of Internal Medicine /Infectious diseases of the Vivantes Auguste-Viktoria-Klinikum. We offer drug studies for patients since 1997.

Will I Become a Guinea-Pig if I Take Part in a Study?

We would not need clinical studies with humans, if only we knew all pros and cons, the efficacy and lack of efficacy of new substances readily at the beginning. Yet this does not make a study participant to a guinea-pig. The most important difference is the complete voluntariness of the participation and the opportunity to withdraw from the study at any point. For this reason studies are not allowed in correctional facilities and the concern of the patient safety of physical integrity is always paramount to the scientific advance and the marketing effort of the pharmaceutical companies.

The patient safety is regulated by German constitutional law and the Declaration of Helsinki of the World Medical Association, the German law on pharmaceutical products (Arzneimittelgesetz) as well as European and international regulations (ICH-GCP). The crucial point is a thorough informed consent with explanation of the advantages and potential risks of the study that will be signed by the patient and the trial physician, as well as insurance for the test persons with high coverage. Before a study can start it has to be approved by an ethics committee. In Berlin it is the ethics committee of the health authorities (Landesamt für Gesundheit und Soziales)

 

Which Advantages Do I Have if I participate in a Clinical Study?

Your benefits can be both, good for your health and good for cost saving. Drugs will be provided by the sponsor and medical examination and treatment is free within the context of the clinical study. In terms of health you may profit a multiple. On the one hand an early treatment with new substances could be presumably more effective, could possibly cause less side effects or the substances are simply more convenient to take. On the other hand you will be examined with the most up-to-date techniques and frequent laboratory analyses, which both will endorse your specialist’s / GPs medical care.

What Will Be Done in the Course of a Clinical Trial?

Your treating physician will check whether your data in the patient record and your actual laboratory results fit into the inclusions and exclusions criteria of the study protocol. The eligibility will be finally checked at the screening visit in the EPIMED central unit in Vivantes Auguste-Viktoria-Klinikum. Many studies have to be placebo controlled and double blind for the scientific scrutiny of the outcome. Therefore, you will be randomized to one of the treatment arms with either the active substance or placebo at the baseline visit. Such studies have a short duration to avoid any harm to the participants. Other studies may last up to several years. The sponsor offers adequate reimbursement for mere research studies with no treatment aspect that involve blood tests of the drug concentration (pharmacokinetics) and a longer stay in the study centre from 8 up to 48 hours. Other studies may include reimbursement of travel expenses.

What Makes EPIMED so Special in Comparison with other Trial Sites?

We put a strong emphasis on the cooperation between the treating physician and the trial physician, between the research and the everyday medical treatment as well as between the hospital and the specialists’ practices. This means that your treating physician receives the study results and the concomitant medication is directly addressed with the treating physician Peripheral Investigators. At EPIMED you are taken care by a team of experienced and competent physicians, study coordinators and study assistants.

Last change: 21-JAN-2020

 

 

 

 

Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH

 

Klinische Studien in Berlin

 

 

EPIMED GmbH

Budapester Str. 15-19

10787 Berlin

Tel. 030 265 583 70

Fax 030 265 583 729

 

 

▶ INTERESSENTEN

 

Medikamentenstudien in Berlin im Bereich Innere Medizin Infektiologie

Bevor ein neues Medikament in die Apotheken kommt, sind viele Schritte nötig. Von der ersten Entwicklung einer möglicherweise helfenden Substanz bis zur arzneimittelrechtlichen Zulassung vergehen in der Regel 10 Jahre.

Viele gutverträgliche Medikamente, die heute selbstverständlich sind, wurden und werden bei EPIMED erprobt und hochwirksame Substanzen, die noch nicht auf den Markt sind, können EPIMED Patienten oft früher bekommen.

Was genau sind klinische Studien?

Es wird zwischen der präklinischen Entwicklung eines Medikaments (Labor „in vitro“, Tierversuche) und den klinischen Prüfungen unterschieden.

Bei den Phase-1(a) Studien kommen die Substanzen das erste Mal zur Anwendung am Menschen. Diese Studien werden mit Probanden durchgeführt, also Versuchsteilnehmern ohne entsprechendes Krankheitsbild und es wird die Verträglichkeit, die Verstoffwechselung und eine eventuelle Schädlichkeit (Toxizität) untersucht. Studien mit Probanden führen wir bei EPIMED nicht durch, wohl aber Phase-1(b) Studien. Das sind Studien, bei denen eine Substanz das erste Mal an Patienten, also Menschen, die das entsprechende Krankheitsbild haben, erprobt wird.

Phase-2 und -3 Studien sind Forschungs- und Therapiestudien mit Patienten. Sie dienen der Untersuchung der Wirksamkeit, der Dosisfindung, der Entwicklung der Darreichungsformulierung, der Erstellung eines Nebenwirkungsprofils und der Langzeitverträglichkeit.

Als Phase-4 Studien bezeichnet man diejenigen Studien, die nach der Zulassung eines Medikaments durchgeführt werden, z. B. eine Untersuchung über die Nebenwirkungen bei Langzeiteinnahme.

Wer führt klinische Studien durch?

Auftraggeber (Sponsoren) sind zumeist pharmazeutische Unternehmen, aber auch staatliche und unabhängige wissenschaftliche Institute. Studien werden in Kliniken, seltener in Arztpraxen durchgeführt.

EPIMED ist ein Zusammenschluss von zwölf Berliner infektiologischen Schwerpunktpraxen und der Klinik für Innere Medizin/Infektiologie des Vivantes Auguste-Viktoria-Klinikums und wir bieten seit 1997 Medikamentenstudien an.

Werde ich mit meiner Teilnahme zum Versuchskaninchen?

Wenn man alles über Vor- und Nachteile, Wirksamkeit oder Unwirksamkeit neuer Substanzen von Anfang an wüsste, bräuchte man keine Studien am Menschen. Das macht aber eine Versuchsperson noch lange nicht zum Versuchskaninchen, denn einer der entscheidenden Unterschiede ist die absolute Freiwilligkeit der Teilnahme und die jederzeitige Möglichkeit, eine Studie wieder abzubrechen. Deswegen sind Studien in Haftanstalten verboten und der wissenschaftliche Erkenntnisgewinn und das Vermarktungsinteresse der Pharmahersteller müssen immer hinter dem Patienteninteresse auf körperliche Unversehrtheit zurücktreten.

Neben dem Grundgesetz regelt die Deklaration des Weltärztebundes von Helsinki, das deutsche Arzneimittelgesetz,  und europäische wie international anerkannte Rechtsnormen (Gute klinische Praxis: ICH-GCP / GCP-V) den Patientenschutz. Kern dessen ist die ausführliche Aufklärung über Vorteile und mögliche Risiken und eine Einverständniserklärung, die Patient und Studienarzt unterschreiben müssen, wie auch der Abschluss einer Probandenversicherung mit hoher Deckungssumme. Bevor eine Studie beginnen kann, wird sie von der jeweilig zuständigen Ethik-Kommission überprüft. In Berlin ist hierfür das Landesamt für Gesundheit und Soziales zuständig.

Welche Vorteile habe ich von einer Studienteilnahme?

Sie können gesundheitlich profitieren und Kosten sparen. In Studien werden die Medikamente vom Sponsor gestellt. Es entfallen die Zuzahlungen und alle Untersuchungen und Behandlungen im Rahmen der Studie sind kostenlos. Gesundheitlich können Sie in mehrfacher Hinsicht profitieren: Zum einen durch die Möglichkeit, früher an neue Substanzen zu kommen, die vermutlich effektiver, nebenwirkungsärmer oder aber einfach bequemer einzunehmen sind. Zum anderen bieten Studien ein engmaschiges Netz an Untersuchungen und Laborkontrollen, die nicht nur nach dem neuesten Stand der Medizin sind, sondern auch die Betreuung durch Ihren Facharzt / Hausarzt ergänzen.

Wie läuft eine Studie ab?

Der behandelnde Arzt schaut, ob Sie aufgrund der Daten Ihrer Krankenakte und aktueller Laborergebnisse den Ein- oder Ausschlusskriterien des Studienprotokolls entsprechen. Zur endgültigen Untersuchung der Geeignetheit, dem so genannten Screening, kommen Sie in die EPIMED Studienzentrale in das Vivantes Auguste-Viktoria-Klinikum. Da eine Vielzahl von Studien zur wissenschaftlichen Überprüfbarkeit von Aussagen Placebo-kontrolliert und verblindet sein müssen, entscheidet sich nach dem Zufallsprinzip vor der so genannten Baseline-Visite, ob Sie in den Studienarm mit dem Wirkstoff oder eben mit einem Placebo kommen. Solche Studien sind sehr kurz, damit man keinen Schaden nimmt; andere Studien können über mehrere Jahre andauern.

Reine Forschungsstudien, bei denen Sie zwecks Blutspiegelmessung (Pharmakokinetik) zwischen 8 und 48 Stunden in die Studienambulanz der EPIMED Studienzentrale kommen müssen, werden von den Sponsoren angemessen aufwandsentschädigt. Bei anderen Studien werden eventuell entstehende Fahrtkosten oder Fahrtkostenpauschalen bezahlt.

Was unterscheidet EPIMED von anderen Prüfzentren?

Wir legen Wert auf eine enge Zusammenarbeit zwischen Hausarzt und Studienarzt, Forschung und medizinischem Behandlungsalltag, Klinik und Schwerpunktpraxis. Konkret bedeutet das, dass bei Ihrer Studienteilnahme dem Hausarzt die Studienergebnisse vorliegen und die Ko-Medikation abgesprochen wird. Bei EPIMED arbeitet ein Team von erfahrenen und kompetenten Ärzten, Studienkoordinatoren und Studienassistenten.

 

Datenschutzerklärung

Verantwortliche Stelle für unsere Website http://www.epimed.org im Sinne der EU-Datenschutzgrund- verordnung (DSGVO) ist die EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH (→ Impressum).

Personenbezogene Daten verarbeiten wir mit Ausnahme der im Rahmen einer freiwilligen Kontakt-aufnahme (→ 5. Kontaktformular) Erhobenen, nur in Form von technischen Prozessen, Plug-Ins, sowie Diensten von Drittanbietern.

1. Cookies

www.epimed.org verwendet einen internen Cookie: pll_language speichert, ob Sie als User diese Seite auf Deutsch oder auf Englisch dargestellt bekommen.

2. Hosting

Unser Host, die domainfactory GmbH Oskar-Messter-Str. 33, 85737 Ismaning hält Ihre IP-Adresse 14 Tage vor. Datenschutzerklärung: https://www.df.eu/de/datenschutz/

3. Google Maps

Wir binden als Serviceleistung die Landkarten des Dienstes Google Maps des Anbieters Google LLC, 1600 Amphitheatre Parkway, Mountain View, CA 94043, USA ein. Datenschutzerklärung: https://www.google.com/policies/privacy . Opt-Out: https://adssettings.google.com/authenticated. Wir weisen darauf hin, dass EPIMED keinerlei Einfluss auf das Tracking Ihrer personenbezogenen Daten dieses eingebetteten Drittanbieters hat.

4. BVG Web-Widget

Wir bieten als Serviceleistung die API BVG Fahrplaninfo. Anbieter sind die Berliner Verkehrsbetriebe AöR , Holzmarktstraße 15-17, 10179 Berlin. Datenschutzerklärung: https://www.bvg.de/de/Serviceseiten/Datenschutzhinweise-BVGdeOnlineshop . Wir weisen darauf hin, dass EPIMED keinerlei Einfluss auf das Tracking Ihrer personenbezogenen Daten dieses eingebetteten Drittanbieters hat.

5. Kontaktformular

Innerhalb unseres Internetangebotes besteht die Möglichkeit der Nutzung eines Kontaktformulars. Erforderlich dafür ist die Angabe einer gültigen E-Mail Adresse. Andere, personenbezogene Daten sind optional. Damit erteilen Sie uns zum Zwecke der Kontaktaufnahme ihre Einwilligung Ihnen zu antworten. Ihre E-Mail Adresse dient uns zur Zuordnung Ihrer Anfrage und deren Beantwortung. In der Beantwortung liegt auch (Art. 6 Abs. I S. 1 f DSGVO). unser berechtigtes Interesse. Eine Speicherung Ihrer freiwillig gemachten weiteren, personenbezogenen Daten in einer Datenbank findet nicht statt. Nach Erledigung der von Ihnen gestellten Anfrage werden Ihre personenbezogenen Daten gelöscht. Ihre Daten werden nicht an Dritte weitergegeben. Wir weisen darauf hin, dass für die Kommunikation per Mail keine vollständige Datensicherheit gewährleistet werden kann.

6. Änderungen

Wir behalten und technische und inhaltliche Änderungen unseres Serviceangebots vor. Sollten diese datenschutzrechtliche Auswirkungen haben, werden wir dementsprechend unsere Datenschutzerklärung anpassen.

7. Ihre Rechte

Als Betroffener stehen Ihnen jederzeit folgende Rechte zu:

  • Auskunft über Ihre bei uns gespeicherten Daten und deren Verarbeitung
  • Löschung oder Berichtigung Ihrer bei uns gespeicherten Daten,
  • Widerspruch gegen die Verarbeitung Ihrer Daten bei uns
  • Jeder Zeit möglicher Widerruf einer Einwilligung für die Zukunft.

Die für Sie zuständige Aufsichtsbehörde bei Beschwerden ist der Berliner Beauftragten für Datenschutz und Informationsfreiheit, Friedrichstr. 219, 10969 Berlin.

Unser externer Datenschutzbeauftragter ist die Sonnemann / Strelecki GbR, Kronenstraße 77, 44139 Dortmund, +49 231 9786951

Wenn Sie Fragen zum Datenschutz haben, schreiben Sie bitte eine E-Mail an datenschutz@epimed.org

Letzte Änderung: 04.10.2018

Nutzungshinweise

1_Taste_gruen_Vorlage

1. Inhalt des Onlineangebotes

Die EPIMEDGesellschaft für epidemiologische und klinische Forschung in der Medizin mbH (kurz „Autor“) hat die auf dieser Web- seite bereitgestellten Informationen sorgfältig erstellt und ist um laufende Überprüfung und Aktualisierung bemüht. Dennoch über- nimmt der Autor keinerlei Gewähr für die Aktualität, Korrektheit, Voll- ständigkeit oder Qualität der auf dieser Webseite bereitgestellten Informationen. Der Autor steht auch nicht dafür ein, dass die Inhalte dieses Internetangebots für den Nutzer und seine Zwecke geeignet sind. Alle Informationen sind freibleibend und unverbindlich. Verbindliche Auskünfte erteilen wir aus- schließlich im Rahmen individueller Kommunikation. Der Autor behält es sich ausdrücklich vor, Teile dieser Webseite oder das gesamte Informationsangebot ohne gesonderte Ankündigung zu verändern, zu ergänzen, zu löschen oder die Veröffentlichung zeitweise oder endgültig einzustellen.

2. Verweise und Links

Dieses Internetangebot enthält Links zu fremden Webseiten. Auf den Inhalt der verlinkten Webseiten hat der Autor keinerlei Einfluss. Die bloße Verlinkung bedeutet auch nicht, dass der Autor die fremden Inhalte billigt oder sich diese zu Eigen macht.  Der Autor übernimmt daher keinerlei Gewähr für die Inhalte der verlinkten Webseiten. Für rechtswidrige, fehlerhafte oder unvollständige fremde Inhalte und insbesondere für Schäden, die aus der Nutzung oder Nichtnutzung dieser fremden Inhalte entstehen, haftet daher allein der Anbieter der jeweiligen Webseite, auf welche verwiesen wurde.

3. Rechte an den Inhalten des Onlineangebots

Der Inhalt, die Gestaltung und der Aufbau dieses Internetangebots sind rechtlich geschützt. Soweit die auf dieser Webseite bereitgestellten  Inhalte einschließlich Bilder, Grafiken und Texte Gegenstand von gewerblichen Schutzrechten des Autors oder Dritter sind, bleiben sämtliche Rechte an solchen Inhalten vorbehalten. Die bereitgestellten Inhalte sind nur für den individuellen Zugriff des Nutzers dieser Webseiten bestimmt. Eine Vervielfältigung, Verbreitung oder sonstige Verwendung dieser Inhalte für geschäftliche Zwecke und/oder in anderen elektronischen oder gedruckten Publikationen ist ohne ausdrückliche Zustimmung des Autors nicht gestattet.4. Rechtswirksamkeit dieses Haftungsausschlusses.

4. Rechtswirksamkeit

Sofern Teile oder einzelne Formulierungen dieser Nutzungshinweise der geltenden Rechtslage nicht, nicht mehr oder nicht vollständig entsprechen sollten, bleiben die übrigen Teile dieses Dokumentes in ihrem Inhalt und ihrer Gültigkeit davon unberührt.

Letzte Änderung: 18.08.2009

Impressum

Verantwortlich

EPIMED- Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH Budapester Str. 15-19, 10798 Berlin

Handelsregister

Amtsgericht Berlin-Charlottenburg HRB 64067

Geschäftsführung

Priv. Doz. Dr. med. Keikawus Arastéh, Dietmar Schranz

Fon / Fax

030 265 583 70  / 030 265 583 729

Aufsichtsbehörde

Landesamt für Gesundheit und Soziales, Berlin

Webadministration

Bastian Krondorfer Fon 030 265 283 720

Gender Mainstreaming

Die auf dieser Website zumeist verwendete männliche Form schließt die weibliche mit ein, sofern aus dem inhaltlichen Zusammenhang nichts anderes hervorgeht.

Dieser Webauftritt dient ausschließlich der Information über die Tätigkeit der EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH im Bereich der klinischen Forschung und. Mit diesem Webauftritt bietet die EPIMED GmbH weder ärztlichen Dienste an, noch werden Produkte oder Dienstleistungen direkt oder indirekt beworben, die nicht Gegenstand des Unternehmens EPIMED GmbH sind. Diesen Webauftritt finanziert die EPIMED GmbH ausschließlich aus eigenen Mitteln. Hier verwendete Markennamen von Prüfmedikamenten dienen ausschließlich der leichteren Verständlichkeit von Studien und sind keinesfalls als Werbung für ein bestimmtes Produkt und dessen Hersteller zu verstehen.

© 2008  ff. EPIMED GmbH. Alle Rechte vorbehalten. EPIMED ® ist ein eingetragenes Markenzeichen.

Letzte Änderung: 18.06.2018

Web-Links

Klinische Forschung Service
Bundesinstitut für Arzneimittel und Medizinprodukte
www.bfarm.de
Berliner Aids-Hilfe e.V.
www.berlin.aidshilfe.de
ClinicalTrials.gov – A service by the U.S. Nat. Institute of Health
clinicaltrials.gov
Deutsche AIDS-Gesellschaft
www.daignet.de/site-Content
EMA – “European Medicine Agency”
www.ema.europa.eu
Deutsche AIDS-Hilfe
www.aidshilfe.de/
FDA – “Food And Drug Administration”
www.fda.gov
HIV im Dialog
www.hiv-im-dialog.de
ICH – “International Conference on Harmonisation”
www.ich.org
HIV&more
www.hivandmore.de
hepatitis&more
www.hepatitisandmore.de
Kompetenznetz HIV/AIDS
www.kompetenznetz-hiv.de
Kompetenznetz Hepatitis
www.kompetenznetz-hepatitis.de
NAM-HIV and AIDS Services Worldwide
www.aidsmap.com
Projekt Information
www.projektinfo.de
Vivantes Netzwerk für Gesundheit
www.vivantes.de
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
www.mvz-mib.dewww.mvz-mib.de
Web-Seiten der EPIMED niedergelassenen Studienärzte finden Sie hier.

Letzte Änderung: 17.11.2015

Unsere Partner (Auswahl)

Industrie

Abbott
Achillion Pharmaceuticals
Ardea Biosciences
Avexa
BionorPharma
Boehringer Ingelheim
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Incyte
Merck Sharp & Dohme
Pfizer
Roche
Janssen
ViiV Healthcare

Contract Research Organisations

Clinical Professionals
ICON Development Solutions
PAREXEL International
PPD GermanyPRAHEALTHSCIENCE
Quintiles
SGS Medisearch International
CRO – Charité Research Organisation

Forschung

CHIP – Copenhagen HIV Program
IATEC Clinical Trial Services
INSIGHT – International Network for Strategic Initiatives in Global HIV Trials

Klinik

Vivantes Auguste-Viktoria-Klinikum:
• Klinik für Innere Medizin, Infektiologie und Gastroenterologie
• Immunologische Tagesklinik

Labore

Covance Central Laboratory Services
Delphic Diagnostic
LabCorp
Labor 28
Labor Berlin Charité Vivantes
MDS Pharma Services – Central Lab
PPD Central Lab
Virco
Quest Diagnostics

Andere

zibp Zentrum für Infektiologie Berlin Prenzlauer Berg
BIOS3 – IT: Software Systeme, Berlin

Letzte Änderung: 07.03.2016

Die HPV-Studie ist bereits geschlossen. Wir nehmen keine weiteren Patienten mehr dafür auf.

Laufende Studien:

Wir suchen noch Patienten für folgende Studiengebiete:

  • bei HIV-Infektion
  • bei Fettleberhepatitis

 

So erreichen Sie uns

Tel. : 030 / 265 583 70

Fax : 030 / 265 583 729

bezüglich Finanzen, Aufwandsentschädigungen und Fahrkostenerstattungen gerne an contact@epimed.org mailen.

unsere Adresse :

Budapester Straße 15-19

10787 Berlin

Da die Parkplätze sehr begrenzt sind, empfehlen wir Ihnen mit den öffentlichen Verkehrsmitteln zu kommen. Sie können aber auch eines der

kostenpflichtigen Parkhäusern in den umliegenden Hotels oder im Lützow-Center in der Keithstraße nutzen.

U-Bahn

mit der U1, U3, U2 Wittenbergplatz, ca. 5 Minuten Fußweg oder

mit der U2, U9 Bahnhof Zoologischer Garten aussteigen, Anbindung Bus 200

Bus

Busline 200 – Haltestelle Budapester Straße

S-Bahn Verbindungen

S3, S5, S7, S9 Zoologischer Garten, Anbindung Bus 200
RE1, RE2, RB 14, RB 21, RB 22 Zoologischer Garten, Anbindung Bus 200

Auszug aus dem Arzneimittelgesetz (AMG)

Neben der GCP-Verordnung regelt das Gesetz über den Verkehr mit Arzneimitteln (AMG) Medikamentenstudien am Menschen in den §§ 40 – 42 im 6. Abschnitt, “Schutz des Menschen
bei der klinischen Prüfung”.

Die Neufassung vom 25. Oktober 2012 finden Sie hier: www.gesetze-im-internet.de

Letzte Änderung: 22.11.2012

Good Clinical Practice: ICH-GCP / GCP-Verordnung

Die konkrete Ausgestaltung der Helsinki-Deklaration wurde in den “Guideline for Good Clinical Practice” der “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH-GCP) als Leitlinie zur Durchführung klinischer Studien niedergelegt.

Mit der europarechtlichen GCP-Richtlinie 2005/28/EU, die durch die 12. Novelle des Arzneimittelgesetzes in deutsches Recht umgesetzt wurde, bekamen die ICH-GCP in Deutschland zwar keine unmittelbare gesetzliche Verbindlichkeit, aber die Leitlinie gilt als grundsätzlich zu befolgendes, antizipiertes Sachverständigengutachten. Die “Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln” (GCP-Verordnung – GCP-V 2006) dagegen ist verbindliche Rechtsnorm.

Die vollständige ICH-GCP finden Sie als pdf-Datei auf der Seite der EMA (European Medicines Agency):

ICH-GCP

Die GCP-Verordnung finden Sie hier:

pdf GCP-V.pdf 132 K

Letzte Änderung: 26.08.2014

Deklaration von Helsinki

Grundlage der klinischen Forschung am Menschen ist die Deklaration des Weltärztebundes von Helsinki 1964 in der revidierten Fassung der 59. Generalversammlung des Weltärztebundes in Seoul, Süd-Korea (englisch).

pdf Declaration_of_Helsinki_Seoul_2008.pdf 57 K

Letzte Änderung: 18.08.2009

CNAB 3002

A randomized, double-blind, comparative, parallel-group, multicentre trial to evaluate the safety and efficacy of 1592U89 versus placebo in combination with background antiretroviral therapy in HIV-infected antiretroviral therapy experienced subjects with CD4+ cell counts ≥ 100cells/mm³ and plasma viral load between 400 copies/ml and 50 000 copies/ml 1997

Peldesine 96-009

Phase I, placebo-controlled study of oral BCX-34 (Peldesine) 1998

Saquinavir SGC G5030 (Racing-Trial)

Pilot Study to evaluate the efficacy and safety of Saquinavir SGC in combination with Zidovudine and Zalcitabine and to optimize the sequence of two different antiviral triple regimes with respect to the development of resistance mutations in HIV-infected patients

M98-863

A randomized, double-blind, phase III study of ABT-378/Ritonavir plus Stavudine and Lamivudine vs. Nelfinavir plus Stavudine and Lamivudine in antiretroviral-naive HIV-infected subjects 1999

M98-888

A randomized, open-label, phase III study of ABT-378/Ritonavir in combination with Nevirapine and 2 nucleoside reverse transcriptase inhibitors (NRTIs) vs. Investigator selected protease inhibitor(s) in combination with Nevirapine and 2 NRTIs in antiretroviral-experienced HIV-infected subjects

MKC-301

A randomized double-blind comparison of MKC-442 versus placebo in antiretroviral-naive patients with HIV-1 RNA 5000 and 50000 copies/ml and CD4+ ³300 cells/mm³  who are initiating therapy with stavudine, lamivudine

DMP 266-006

Multizentrische, randomisierte, offene Phase III-Studie zum Vergleich der antiretroviralen Aktivität und Verträglichkeit drei verschiedener Kombinationstherapien bei HIV-infizierten Patienten (DMP-266 plus Indinavir, DMP-266 plus Zidovudin plus Lamivudin, Indinavir plus Zidovudin plus Lamivudin

DMP 266-027

Eine offene, randomisierte, multizentrische Studie der Phase II bei HIV-1 infizierten Patienten zur Bewertung der Sicherheit und Dauer der Virussuppression unter einer fortgesetzten Standardtherapie bestehend aus einem Protease-Inhibitor und zwei Nukleosidalen Reverse Transkriptase-Inhibitoren im Vergleich zu zwei neuen Therapieschemata, in denen entweder die Nukleosidalen Reverse Transkriptase-Inhibitoren oder der Protease-Inhibitoren durch DMP 266 ersetzt wird.

MKC-302

A randomized double-blind comparison of MKC-442 versus placebo in antiretroviral-naive patients with HIV-1 RNA >5000 and £300 000 copies/ml and CD4+ >300 cells/mm³ who are initiating therapy with stavudine, didanosine

MKC 502

An open-label extension study for patients on an emivirine containing regimen (roll over protocol for the MKC-301 and 302 being conducted in Europe)

APV 20001

A phase II randomised, multicenter, partially blinded, crossover study to assess the safety, tolerability, pharmacokinetics, and antiviral effect of two doses of GW433908 compared to Amprenavir (1200 mg bid) when given for 28 days to subjects infected with HIV-1

SU 5416.003

A multicenter, dose escalating study in patients with cutaneous AIDS-related Kaposi’s Sarcoma

SU 5416.301

A multicenter, open-Label, phase II study of the efficacy and saftety of SU5416 in patients with therapy refractory cutaneous AIDS-related Kaposi’s Sarcoma

DMP 266-053

Eine multizentrische, offene Phase III Studie zum Vergleich der antiretroviralen Aktivität, Verträglichkeit und Sicherheit von drei verschiedenen Kombinationstherapien bestehend aus: Efavirenz + Stavudine + Didanosin / Abacavir + NRTI + Lamivudin / Stavudin + Didanosin + Indinavir bei HIN-infizierten Patienten. Eine Folgestudie für die Studie DMP 266-006

NNR 20001

GW433908 vs. amprenavir

Switch

Ersatztherapie nach dreifach kombinierter Induktionstherapie zur Verlängerung des Netto-Therapieeffektes durch Verzögerung der Resistenzentwicklung bei HIV-1 infizierten Patienten (multizentrische, randomisierte, open-label Studie).

SILCAAT

A phase III, multicenter, randomized trial on the biological and clinical efficacy of subcutaneous, recombinant human Interleukin-2 in HIV infected patients with low CD4+ count by active, antiretroviral therapy 2000

Great Study

A randomized international, parallel group, open label comparison of the efficacy of second line antiretroviral therapy chosen based on best clinical judgment, or best clinical judgment plus HIV resistence genotyping supported by HIV Resistance Support Software interpretation, in HIV infected patients failing their first protease containing regime.

GF 9037 (Serostim)

A randomized, parallel group, double-blind, placebo-controlled, dose-ranging, multicenter study of recombinant human growth hormone (Serostim) in the treatment of HIV associated catabolism/wasting

DPC 083-201

A phase II, randomized, double-blind, dose-ranging study to assess the safety and tolerability of three doses of DPC 083 versus Efavirenz, in combination with open-label Zidovudine and Lamivudine, in antiretroviral-naive, HIV-1-infected subjects

GS-99-903 (Tenofovir)

A phase III randomized, double-blind, multicenter study of the treatment of antiretroviral-naive, HIV-1-infected patients comparing with Lamivudine and Efavirenz versus Stavudine, Lamivudine and Efavirenz

Saquinavir Pharmakokinetik

Comparative pharmacokinetics of twice-daily saquinavir administered as the soft gel capsule formulation or the hard gel capsule formulation in combination with ritonavir

APV 30002

A randomized, open label two arm trial to compare the safety und antiviral efficacy of GW 433908/Ritonavir to Nelfinavir BID when used in combination with Abacavir and Lamivudine BID for 48 weeks in antiretroviral therapy naive HIV-1 infected subjects

FTC-301

A randomized, double-blind, equivalence trial comparing Emtricitabine to Stavudine with a triple drug combination containing Didanosine plus Efavirenz in antiretroviral drug naive HIV-1 infected patients 2001

TORO 1 / TORO 2   RO 29-9800 T20-302/BV 16052

A phase III open-label, randomized, active, controlled study assessing the efficacy and saftey of T20 / Ro 29-9800 (HIV-1 fusion inhibitor) in combination with an optimized background regimen, versus optimized background regimen alone, in patients with prior experience and/or prior documented resistance to each of the three classes of approved antiretrovirals (nucleoside reverse transciptase inhibitors, non-nucleosids reverse transcriptase inhibitors and protease inhibitors)

BI 1182.6 (Tipranavir)

A phase IIa open-label multinational study of the effects of three dose pairs of Tipranavir/Ritonavir (b.i.d.) on the pharmacokinetic characteristics of protocol-defined, baseline, triple drug nucleoside and non-nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected subjects.

DPC 083-203

A Phase II randomized, double-blind, multicenter study to assess the safety and efficacy of two doses of  DPC 083, in combination with open-label Nucleoside Analog Reverse Transcriptase Inhibitors in HIV-1–infected subjects who are failing treatment with a non-nucleoside reverse transcriptase inhibitor-containing regimen

APV 30003

A phase III, randomized, multicenter, parallel group, open-label, three arm study to compare the efficacy and safety of two dosing regimes of GW433908/Ritonovir (700mg/100 mg twice daily or 1400mg/200mg once daily) versus Lopinavir/Ritonavir (400mg/100mg twice daily) for 48 weeks in protease inhibitor experienced HIV-infected Adults experiencing virological failure

CNA 30021 (Zodiac)

A phase III, 48-week, randomised, double-blind, multicenter study to evaluate the safety and efficacy of Abacavir 600 mg once-daily (QD) vs. Abacavir 300 mg BID in combination with Lamivudine 300 mg QD and Efavirenz 600 mg QD in antiretroviral therapy naive HIV-1 infected subjects

TMC125-C207

Efficacy of an 8-day treatment (7 days b.i.d. and 1 day o.d.) with 900mg TMC125 in HIV-1 positive subjects with phenotypically confirmed NNRTI resistance

GS-00-951 (Tenofovir EAP)

Eine offene Phase IIIb Studie zur Sicherheit und Verträglichkeit von Tenovovir Disoproxil Fumarat bei der Behandlung von HIV-infizierten Patienten mit begrenzten Behandlungsmöglichkeiten

BI 1100. 1359

Investigation of pharmacokinetic interaction of nevirapine and Methadon in HIV-infected patients under combination treatment with various NRTIs, phase IV

TMC114-C201

A phase IIa open, randomized trial to determine the antiviral activity in 60 HIV positive subjects with multiple PI resistant strains, receiving either control treatment or a daily dose of 800, 1600, 2400 or 3600 mg for 13 days followed by a single dose on day 14

AXDC-1(AXD455)

A phase-IIa repeat dose-rising study to explore the safety, efficacy and pharmakokinetics of intravenous AXD 455 doses in HIV-infected patients with multi-resistance or intolerable side effects on haart

DPC 083-303

A Phase III, randomized, double-blind, multicenter study to acess the safety and   efficacy of DPC 083 versus Nelfinavir in combination with AZT/3TC (i.e. Zidovudine and Lamivudine) in antiretroviral-naive HIV‑1‑infected subjects

TMC125-C203/ C209

A randomized, placebo-controlled phase II trial in HIV-1 infected, NRTI-, PI- and NNRTI-experienced subjects to evaluate the safety, tolerability and efficacy of different doses of TMC125 b.i.d. on top of an individually optimized antiretroviral therapy by means of a 3-stage dose-escalating design 2002

BI 1182.52 (Tipranavir)

A phase IIb double-blind, randomized, dose optimization trial of three doses of Tipranavir boosted with low dose Ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects.

TMC114-C207

A phase IIa open, randomized trial to determine the antiviral activity in HIV-1 positive subjects with multiple PI resistant strains, receiving either control treatment or TMC 114/Ritonavir treatment at various dosages for 13 days followed by a single dose on day 14

P00738-65 (PEG-Intron)

Klinische Prüfung der Phase 3 zu PEG-Intron bei intensiv behandelten HIV infizierten Patienten

CI-PSI-004-02-101 (Racivir)

A phase I study exploring the safety, tolerability, pharmacokinetics and virological effect of RCV after 14 days of oral ascending doses of 200, 400 and 600 mg RCV when used in combination with Efavirenz and Stavudine in HIV-infected men

APV 30005

An open-label phase III study to assess the long term safety profile of GW33908 containing regimens in HIV-1 infectect subjects

BI 1182.48 (RESIST-2)

Randomized, open-label, comparative safety and efficacy study of Tipranavir boosted with low-dose Ritonavir versus genotypically-defined Protease Inhibitor/Ritonavir in multiple antiretroviral drug-experienced patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir) 2003

BI 1182.17

A long-term open-label roll-over trial assessing the safety and tolerability of combination Tipranavir and Ritonavir use in HIV- infected subjects

BI 1182.51

An open label, randomized, parallel group pharmacokinetics trial of tipranavir / ritonavir (TPV/TRV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced patients

Kinesa

Simultaneous boosting of Nelfinavir and Saquinavir by small doses of Ritonavir: a pharmakokinetic study in HIV-infected patients

TMC114-C213

A phase II randomized, controlled (standard of care), partially blinded, 48-week trial to investigate dose response of TMC114/rtv in 3-class-experienced HIV-infected subjects 2004

TMC114-C215

An open-label trial of TMC114/rtv in HIV-1 infected, treatment experienced subjects

BI 1182.33

A phase IIb/III randomised, open label, active controlled trial to evaluate the antiviral efficacy and safety of treatment with 500 mg Tipranavir plus 100 mg or 200 mg Ritonavir p.o. BID in combination with standard background regimen in comparison to 400 mg Lopinavir plus 100 mg Ritonavir p.o. BID in combination with standard background regimen in antiretroviral therapy naïve patients for 48 weeks

INCB 8721 RVT-203 (Reverset)

A phase II placebo-controlled, double-blind, parallel dose group study exploring the safety, tolerability and virological effect of 50, 100 and 200 mg RVT in HIV-infected antiretroviral therapy-experienced subjects when used in combination with other antiretroviral agents

R27874-C202

A phase II, proof of principle, randomized, open-label trial in HIV-infected subjects with NNRTI experience and/or genotypic evidence of NNRTI resistance, who will receive R27874 once daily for 7 days in substitution for the NNRTI or PI in failing ART

TMC125-C141

A Phase I ,open-label, randomized, single dose, cross-over study to evaluate the relative bioavailability of 3 dose levels of TMC125 in HIV-1 infected subjects as a spray-dry formulation compared to the reference formulation TF035.

INCB 8721 DFC-901 (Reverset r-o)

A long-term open-label non-randomized study to evaluate the safety of 100 and 200 mg ReversetTM (RVT) in HIV-infected antiretroviral therapy-experienced subjects when used in combination with other antiretroviral agents 2005

A4001028

A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5-antagonist, UK-427,857, in combination with OBT versus OBT alone for the treatment of antiretroviral-experienced HIV-1-infected subjects

A4001029 (Motivate)

A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5-antagonist, UK-427,857, in combination with OBT versus OBT alone for the treatment of antiretroviral-experienced non CCR5-tropic HIV-1-infected subjects

CCR102881 (ASCENT)

A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW 873140 in combination with AZT/3TC (Lamivudine + Zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naïve adults

TMC125-C228

A Phase I randomized, open-label, multiple dose, cross-over trial in HIV-1 infected subjects to evaluate the relative bioavailability of TMC125 as a spray-dry formulation compared to the reference formulation TF035

TMC 278-C204

A phase IIb randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naïve HIV-1 infected subjects. EudraCT No. 2004-004055-19.

TMC114-C208

An open label trial of TMC114/rtv in HIV-1 infected subjects who were randomized in the trials TMC114-C201, -207 or in sponsor selected phase-I-trials

TMC114-C214

A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/RTV versus LPV/RTV in treatment-experienced HIV-1 infected subjects. EudraCT No. 2005-000594-22

TMC125-C229

An open-label trial with TMC125 in HIV-1 infected subjects, who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial and were treated for at least 48 weeks

TMC125-C216 (DUET 2)

A Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options. [IND No. 63646] – A substudy of TMC125-C216 to evaluate the pharmacokinetic profile of TMC125, TMC114 and RTV at Week 4 and 24, co-administered with an individually optimized antiretroviral therapy 2006

TMC125-C217

An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216)

TMC 114-C211 (ARTEMIS)

A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/Ritonavir versus Lopinavir/Ritonavir in treatment-naive HIV-1 infected subjects. This trial will be referred to as ARTEMIS. EudraCT No. 2005-002486-36

AI 424-138 (CASTLE)

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir with Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment Naïve Subjects

BI 1100.1452

A Case-Control Toxicogenomics Study to Identify Genetic Locus or Loci in Patients who have Experienced Symptomatic Hepatotoxicity and Severe Skin Rash within the First 8 weeks of Nevirapine Therapy. EudraCT No. 2005-004321-26

MK-0518-018 (BENCHMARK-1)

A multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of MK-0518 in combination with an optimized background therapy (OBT) versus optimized background therapy alone, in HIV Infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies. 
 EudraCT No. 2005-005127-34.

BI 1100.1470 (ARTEN)

Open-label, randomised clinical trial to compare the virological efficacy and safety of Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine vs. Nevirapine on same background, in HIV-1-infected patients who have received no previous antiretroviral treatment. EudraCT No. 2005-004330-40.

MK-0518 032-00

A randomized, double blind, two-armed trial to evaluate the efficacy and safety of MK-0518 versus LPV/RTV in patients with maximum suppression with LPV/RTV 2007

BI 1100.1498 (ERVIR)

Steady State Bioavailability of 2 different Viramune Extended Release formulations compared to steady state 400 mg of Viramune (200 mg BID) in HIV infected subjects, an open label, non randomized, multidose and multistage parallel group study.

ACH443-014A

A 14-Day, Randomized, Double-blind, comparative viral kinetic study of  Elvucitabine  versus Lamivudine administered  once daily to HIV-1 infected subjects with a documented M184V variant

ACH443-018

An open-label, 24-week extension study of Elvucitabine administered in combination with background antiretroviral agents in subjects who have completed 14 days of treatment in protocol ACH443-014A 2008

BI 1182.107

A multicenter, randomized, open label, clinical trial to evaluate three doses of tipranavir boosted with ritonavir (500 mg/200 mg qd, 250 mg/100 mg bid and 500 mg/100 mg bid) by assessing the steady-state pharmacokinetics and short-term efficacy and Safety in HIV-1 positive treatment naïve patients

BI 1100.1486 (Verxve)

A randomised, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400 mg QD Nevirapine extended release formulation in comparison to 200 mg BID antiretroviral therapy naïve HIV-1 infected patients. EudraCT No. 2007-003654-29.

BI 1241.2

Safety, antiviral activity and pharmacokinetics of multiple oral doses of BI 207127 NA administered q8H for 5 days as monotherapy: a randomised, double-blind, placebo controlled study. 
 EudraCT No. 2007-004068-38.

AVX-301

A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of Apricitabine versus Lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase. EudraCT No. 2007-003281-18.

TMC 278-TiDP6-C215 (Thrive)

A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus Efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects. EudraCT No. 2007-002647-25.

BI 1100.1526 (Tranxition)

An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400 mg QD or remaining on Nevirapine IR 200 mg BID based regimen. EudraCT No. 2008-004681-55.

BI 1220.5

Antiviral effect, safety and pharmacokinetics of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 24 weeks as combination therapy with pegylated interferon-α 2a and ribavirin (double-blinded, randomised, placebo-controlled, Phase II). EudraCT No. 2008-003538-11.

112353 (TH-HIV-010 PRI)

A Phase I, randomised, placebo controlled, observer blind, multicentre study to determine safety and reactogenicity of F4co/AS01B vaccine, administered intramuscularly according to a 0, 1 Month schedule in HIV-infected subjects aged 18-55 years. EudraCT No. 2008-005009-20. 2009

CT-BI Vacc-4x 2007/1

A Phase II, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ART. 
 EudraCT No. 2007-006302-13.

A4001078

Pilot Study of  novel Combination of Maraviroc + Atazanavir/Ritonavir vs Atazanavir/Ritonavir + Tenofovir/Emtrici- tabine for the treatment of Treatment naive HIV-infected patients with R5 HIV-1. EudraCT No. 2008-007038-24.

TMC 310911-TiDP-21-C201

A Phase IIa, open-label, randomized trial in treatment-naive HIV-1-infected subjects to determine the antiviral activity of 14 days of monotherapy with 2 different b.i.d. dose regimens of TMC310911 co-administered with ritonavir. EudraCT No. 2008-008190-58

MK-7009

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection. 
 EudraCT No. 2008-000150-12.

BI 1241.7

Safety, antiviral activity, and pharmacokinetics of BI 207127 NA administered in combination with Peg-IFN and ribavirin in chronic HCV infected patients for 4 weeks, a randomised, double-blind, placebo controlled study. EudraCT No. 2008-008292-34.

TMC435-TiDP16-C205 (Pillar)

A Phase IIb, randomized double-blind, placepo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve genotype 1 hepatitis C-infected subjects. EudraCT No. 2008-007147-13.

TMC435-TiDP16-C206 (Aspire)

A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNα-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNα-2a/b and RBV therapy. EudraCT No. 2009-010590-20.

START

Strategic Timing of AntiRetroviral Treatment (START) to determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, non-AIDS, or death from any cause. EudraCT No. 2008-006439-12

BI 1241.21 (SOUND)

Safety, antiviral effect and pharmacokinetics of BI 207127 incombination with BI 201335 and with ribavirin for 4 (Part 1) and with or without ribavirin for 24-48 weeks (Part 2) in patients with chronic HCV genotype 1 infection (randomized, open label, Phase II). EudraCT No. 2009-018197-66

A8121014 (Fitness)

(Filibuvir in Treatment Naïve HCV Genotype 1 Subjects) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Filibuvir Plus Pegylated Interferon Alfa-2a and Ribavirin in Treatment naïve, HCV Genotype 1 Infected Subjects. EudraCT No. 2009-009214-40 2010

GS-US-216-0114

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No. 2009-016759-22

TMC435HPC3002

A prospective 1-year virological follow-up study in subjects previously treted in Phase IIb or Phase III study with a TMC435-containing regimen for the trearment of hepatitis C virus (HCV) infection. 2011

TMC278-TiDP6-C222

An open-label trial with TMC275 25mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide revers transcriptase inhibitors in HIV-1 infected subjects, who partici- pated in TMC278 clinical trials. EudraCT No.: 2010-021209-18

ING114467 (SINGLE)

A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/ lamivudine fixed dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naïve aduld subjects. EudraCT No. 2010-020983-39

GS-US-264-0106 (SPIRIT)

A Phase 3 Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically-Suppressed, HIV-1 Infected Patients.  EudraCT No. 2010-023178-37

BI 1220.30

Efficacy and safety of once daily BI 201335 for 12 or 24 weeks in combination with pegylated interferon-α and ribavirin in treatment naïve patients with genotype 1 chronic hepatitis C infection (double-blinded, randomised, placebo-controlled, Phase III). EudraCT No. 2010-021716-42

BI 1220.7

A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 for 24 weeks in combination with pegylated interferon-α and ribavirin in patients who failed to a prior PegIFN / RBV treatment with genotype 1 chronic hepatitis C infection. EudraCT No.: 2010-021715-17

A4001098

A Multicenter, Randomized, Blinded, Placebo-Controled Study to evaluate the Safesty of Maraviroc in Combination with other Antiretroviral Agents in HIV-1-Infected Subjects Co-Infected with Hepatitis C and/or Hepatitis B Virus. EudraCT No. 2010-021994-35

BI 1220.48

A phase III, open-label, study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-α and ribavirin in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN / RBV treatment. EudraCT No.: 2011-000347-25

GS-US-264-0110 (STAR)

A Phase 3B, Randomized, Open-label Study to Evaluate theSafety and Efficacy of a Single Tablet Regimen of Emtricitabine/ Rilpivirine/Tenofovir Disoproxil Fumarate Compared with a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No. 2010-024007-27

BI 1220.19

Safety and Efficacy of 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HC V-co-infected patients. A multinational, randomised, parallel group, open-label trial. EudraCT No.: 2010-021734-59

AI438-011

A Phase IIb Randomized, Controlled, Partially Blinded Trial to Investigate Safety, Efficacy and dose-response of BMS-663068 in Treatment-experienced HIV-1Subjects, Followed by an Open-label Period on the Recommended Dose. EudraCT No.: 2011-000437-36

A4001095 (MODERN)

Multizentrische, randomisierte, doppelblinde Vergleichsstudie zu Maraviroc und Darunavir/Ritonavir versus Emtricitabin/ Tenofovir + Darunavir/Ritonavir zur Behandlung nicht antiretroviral vorbehandelter HIV-Patienten mit CCR5-tropem HIV-1. EudraCT No.: 2010-021785-30

TMC647055HPC1005

A Phase I, open label trial in genotype 1 HCV-infected subjects to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir. EudraCT No.: 2011-004028-37 2012

GS-US-236-0115

A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients. 2011-004483-30

AI447-028 (DUAL)

A Phase 3 Study with Asunaprevir and Daclatasavir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligibleto P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection. EudraCT No.:  2011-005446-35

CT-BI Vacc-4x/IMiD-2010/1

Randomized, Double-blind Placebo Controlled, Multicenter, Immunogenicity Pilot Study of Vacc-4x + Revlimid Versus Vacc-4x in Subjects Infected with HIV-1, on Antiretroviral Therapy (ART). EudraCT No.: 2011-001217-13

CT-BI Vacc-4x 2012/1

Re-boosting of Subjects Previously Included in the Phase IIB Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART. EudraCT No. 2012-002281-12

GS-US-236-0121 (STRATEGY)

A Phase 3b Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients  EudraCT No.: 2011-004963-56

MK 1439-007

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK- 1439 Plus TRUVADA Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients. EudraCT No.: 2012-001573-93

BI 1241.30

A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1 chronic hepatitis C infection. EudraCT No. 2012-003534-17 2013

BI 1241.20

A phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 HCV Infection. EudraCT No.: 2012-03533-41

GS-US-292-0109

A Phase 3, Open-Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects. EudraCT No.: 2012-005114-20

TMC647055HPC2001

A Phase IIa, open-label trial to evaluate the safety, tolerability and efficacy of a 12 weeks combination therapy of TMC647055 and TMC435, with and without GSK2336805, with a pharmacokinetic enhancer with and without ribavirin in chronic genotype 1 hepatitis C infected patients. EudraCT No. 2012-002555-42 2014

MK 0518-292

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir  (MK-0518) 1200 mg Once Daily Versus Raltegravir (MK-0518) 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects. EudraCT No.: 2013-001939-47

ASTRAL-3 GS-US-342-1140

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection. EudraCT-No.2014-001682-27

ASTRAL-1 GS-US-342-1138

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV. EudraCT-No. 2014-001683-35

MK 1439-018 Drive Forward

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA™ or EPZICOM™/ KIVEXA™in Treatment-Naïve HIV-1 Infected Subjects. EudraCT No.: 2014-001127-69

GS-US-342-1446

An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection.EudraCT-No. 2014-003898-42 2015

GS-US-380-1489

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/ Emtricitabine/ Tenofovir Alafenamide Versus Abacavir/Dolutegravir/ Lamivudine in HIV-1 Infected Antiretroviral Treatment-Naïve Adults. EudraCT No.: 2016 2015-004024-54 2016

MK 3682-011 C-Crest

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT1, GT2, and GT4 Infection. EudraCT-No.: 2014-003304-73

201637 SWORD

A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-,NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed. EudraCT No.: 2014-005148-16

MK 1439A-021 Drive Shift

A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) EudraCT No.: 2014-005550-18

MK 1439A-021 Drive Ahead

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects. EudraCT No.: 2014-003382-17

AI468-038

A Phase 2b Randomized, Active-Controlled, Double-blind Trial to Investigate Safety, Efficacy and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults. EudraCT No.: 2013-005487-26

TMC114FD2HTX3001 AMBER

A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/ tenofovir alafenamide once-daily single-tablet regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination combined with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects. EudraCT No.: 2015-000754-38

GS-US-292-1823

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV‑1 Infected Adult Subjects. EudraCT No.: 2015-002711-15

GS-US-380-1878

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults. EudraCT No.: 2015-004011-20

GS-US-380-1844

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed. EudraCT No.: 2015-004025-14

GS-US-380-4030

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects who are Virologically Suppressed. EudraCT No.: 2017-000308-17

Letzte Änderung: 20.01.2020

Aktuelle Studien

 

HPV

V503-049

A Phase 3, International, Multi-center, Randomized, Double-blind, Placebocontrolled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age. EudraCT No.

HBV

73763989HPB2001

A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection – The REEF-1 Study. EudraCT No. 2019-000622-22

HIV

MK-8591A-018

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to MK-8591A Once-Daily in HIV-1-Infected Participants Virologically Suppressed on bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) EudraCT No. 2019-000587-23

FindHIV

Frühzeitige Identifikation mittels normierter Diagnosekriterien für die HIV-Infektion. (dagnä-Studie)

204862 TANGO

A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV 1 infected adults who are virologically suppressed. EudraCT No.:2015-004401-17

207966 ATLAS 2M

A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults who are Virologically Suppressed. EudraCT No.: 2017-002946-62

201585 ATLAS

A Phase III, randomized, multicenter, parallel-group, noninferiority,open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus longacting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who arevirologically suppressed. EudraCT No.: 2016-001646-25

201584 FLAIR

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants.  EudraCT No.: 2016-001646-25

GS-US-380-1490

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/ Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. EudraCT No.: 2015-003988-10

AI438-047

A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1. EudraCT No.: 2014-002111-41

200056 LATTE-2

A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/ Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects. EudraCT No.: 2013-000783-2

Letzte Änderung: 07-JUL-2020

 

Niedergelassene Ärzte

 
Dr. Ulrich Bohr

 

 

 

Facharzt für Innere Medizin / Gastroenterologie, Infektiologie, Suchtmedizinische Grundversorgung

 

 

 

Praxiszentrum Kaiserdamm, Kaiserdamm 24, 14057 Berlin, Fon 030  301 13 90 www.praxiszentrum-kaiserdamm.de

 

Dr. Christiane Cordes
  Fachärztin für Allgemeinmedizin / Infektiologie (DGI)  

Warschauer Str. 33, 10243 Berlin,
Fon 030 97 00 22 88 www.drcordes.de

 
Klaus Fischer

 

 
Dietmar Schranz

 

 

 

Facharzt für Innere Medizin

 

 

Facharzt für Innere Medizin / Infektiologie

 

  Praxis Wilmersdorf, Wilmersdorfer Str. 62, 10627 Berlin, Fon 030 892 94 88 www.schranzundfischer.de
Matthias Freiwald
  Facharzt für Allgemeinmedizin   Ärztezentrum Nollendorfplatz, Nollendorfplatz 3-4, 10777 Berlin, Fon 030 219 676 50 www.aerztezentrum-nollendorfplatz.de
Dr. Tobias Glaunsinger
  Facharzt für Allgemeinmedizin, Infektiologe (DGI und ÄK Berlin)    Praxis Prenzlauer Berg, Danziger Str. 78 b,
10405 Berlin, Fon 030 440 399 72
www.praxis-prenzlauer-berg.de
Dr. Roland Grimm
  Facharzt für Allgemeinmedizin   Schwerpunktpraxis Mitte, Linienstr. 127, 10115 Berlin, Fon 030 282 50 52 www.spp-mitte.de 
 
Dr. Heribert Hillenbrand
 
 
Dr. Heiko Karcher

 

 

Facharzt für Innere Medizin, Infektiologe (DGI)

 

 

Facharzt für Innere Medizin und Infektiologie (DGI)

  PraxisCityOst – Medizinisches Versorgungszentrum Berlin- Friedrichshain, Gubener Str. 37, 10243 Berlin,
Fon 030 293 639 50 www.praxiscityost.de
Dr. Arne Jessen
  Facharzt für Allgemeinmedizin / Infektiologie (DGI)   Praxis Jessen² + Kollegen, Motzstr. 19, 10777 Berlin, Fon 030 235 10 70 www.praxis-jessen.de
Dr. Gerd Klausen
  Facharzt für Allgemeinmedizin   Schwerpunktpraxis Mitte, Linienstr. 127, 10115 Berlin, Fon 030 282 50 52 www.spp-mitte.de
Siegfried Köppe
 
Peter Kreckel

 

 

Facharzt für Innere Medizin / Infektiologie (DGI)

 

Facharzt für Innere Medizin

 

  Internistische Gemeinschaftspraxis m-50, Mehringdamm 50, 10961 Berlin,
Fon 030 789 926 35 www.m-50.de
Dr. Ingo Ochlast
   Facharzt für Allgemeinmedizin und Arbeitsmedizin   Praxisteam Friedrichshain, Petersburger Str. 94, 10247 Berlin, Fon 030 420 82 47 70 www.praxisteam-friedrichshain.de
Dr. Michael Rausch
  Facharzt für Innere Medizin / Infektiologie (DGI)   Ärztezentrum Nollendorfplatz, Nollendorfplatz 3-4, 10777 Berlin, Fon 030 219 676 50 www.aerztezentrum-nollendorfplatz.de
Kevin Ummard-Berger
  Facharzt für Allgemeinmedizin  

UBN Praxis Königin-Elisabeth-Straße 7, 14059 Berlin, Fon 030 / 767 333 70 https://www.ubn-praxis.de/kontakt

Dr. Christoph Schuler
  Facharzt für Allgemeinmedizin / Infektiologe   Praxisgemeinschaft Turmstraße, Turmstr. 76A, 10551 Berlin, Fon 030 391 10 21 www.praxis-turmstrasse.de
Thomas Wicke
  Facharzt für Allgemeinmedizin  
Novopraxis Berlin, Mohrenstraße 6, 10117 Berlin, Fon 030 34620300 www.novopraxis.Berlin

Letzte Änderung: 25.05.2021

Über uns

Berliner niedergelassene Ärzte mit Schwerpunkt in der Versorgung von Menschen mit HIV und viralen Hepatitiden und die damalige Klinik für Innere Medizin / Infektiologie des Vivantes Auguste-Viktoria-Klinikums und aktuell des St. Joseph Krankenhauses haben sich zum Wissenschaftsunternehmen‚ EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH zusammengeschlossen, um ein gemeinsames Netzwerk zur Planung und Durchführung von wissenschaftlichen Vorhaben und klinischen Studien aufzubauen.

Das Konzept von EPIMED ist das einer Independent Clinical Research Facility; die Verknüpfung von guter (haus)ärztlicher Versorgung einerseits und hervorragender Qualität der in den klinischen Prüfungen erhobenen Daten andererseits, die wir bei der Durchführung von Phase I-III Studien gewährleisten. Mit über 140 Studien in 20 Jahren können wir nicht ohne Stolz darauf verweisen, an vielen entscheidenden Entwicklungen von Substanzen, insbesondere in der ART-Forschung, mitgewirkt zu haben.

EPIMED versteht sich darüber hinaus als selbstverständlicher Teil des Berliner „Schöneberger Model“, das mit Beginn der AIDS-Pandemie richtungweisend Kliniken und niedergelassene Ärzte, Forschung und Versorgung, Prävention und Behandlung, AIDS-Hilfen und Pflege miteinander verbindet.

Lesen Sie bitte mehr zu unserem Know-How, zu unserer Struktur und Ausstattung und zu unseren Angeboten im Menü Für Sponsoren.

 

Team Studienzentrale

Dr. med. Christina Sophie Engelhard

Seit Juni 2020 Teamleitung und als medical clinical studies research manager verantwortlich für die generellen, organisatorischen Abläufe in der Studiendurchführung, sowie Ansprechpartnerin für Sponsoren und Kollegen in den peripheren Einheiten. Sie ist ausgebildete Fachärztin für Innere Medizin und stieß im Januar 2019 zum EPIMED-Team, nachdem Sie seit 2014 als Assistenzärztin im Helios Klinikum Berlin Buch in den Bereichen Hämatologie, Onkologie, Tumorimmunologie, Stammzellentransplantation und Intensivmedizin gearbeitet hatte. In enger Zusammenarbeit mit dem Hauptprüfer Dr. Arastéh liegt Ihr Schwerpunkt als Prüfärztin der EPIMED-Zentrale in der Beurteilung neu eingereichter Studien-Protokolle, der Überprüfung der source-data und der Rücksprache mit den Schwerpunktärzten, Sponsoren und CROs. Sie führt Patientenaufklärungen und Screening-Visiten durch, bewertet Laborbefunde und SUA-Reports.

 
Michael Rittweger

Facharzt für Innere Medizin und stellvertretender Prüfer, kam im Jahr 2004 zu EPIMED. Er ist ist heute neben seiner Tätigkeit für EPIMED, niedergelassener Arzt in der praxiswilmersdorfer in Berlin. Er hat seit 2002 zahlreiche klinische Studien inner- und außerhalb von EPIMED betreut.

Josephine Fink

ist seit September 2020 Study-Coordinator bei EPIMED. Sie ist ausgebildete MFA und arbeitete zuvor in einigen Hausarztpraxen, zuletzt war sie in der Kantpraxis mit rheumatologischen und gastroenterologischem Schwerpunkt. Sie betreut eigene Studien beginnend bei der Konzeption und gesamten Durchführung. Mit ihrer äußerst schnellen Auffassungsgabe optimiert sie zudem viel interne Prozesse.

 


Meltema Friedrich

ist seit März 2020 Study-Coordinator bei EPIMED. Sie ist examinierte Krankenpflegerin und arbeitete zuvor als Studienkoordinatorin in der gynäkologischen Klinik der Charité, Campus Virchow. Sie ist verantwortlich für die Visitenplanung zahlreicher Studien, für die Erstellung von Worksheets, für Labor- und Medikamentenlogistik, für Visitendokumentation und Eingabe und Pflege von Studiendaten.

 
Sophia Charlotte Garoes

Study coordinator …..

Dietmar Schranz

ist seit 1999 Geschäftsführer der EPIMED GmbH und als niedergelassener Arzt einer Schwerpunktpraxis in Berlin-Charlottenburg von Anfang an beteiligt an EPIMED-Studien. Seine Führungs- und Planungsaufgaben umfassen die Überprüfung der Verantwortbarkeit und Machbarkeit von Studienangeboten und die Leitung der regelmäßigen Studienbesprechungen der beteiligten EPIMED-Studienärzte.

Priv. Doz. Dr. Keikawus Arastéh,

Prüfer, ist zusammen mit Dietmar Schranz Geschäftsführer der EPIMED GmbH mit Schwerpunkt auf der Akquise von Studien. In seiner Funktion obliegt ihm die Gesamtverantwortung über alle Prüfungen bei EPIMED. Seit 1991 führt er Studien im Bereich HIV/AIDS und angrenzenden Indikationsfeldern durch, hat dazu in zahlreichen Fachzeitschriften publiziert und ist Mitautor der Deutsch-Österreichischen Leitlinien zur antiretroviralen Therapie der HIV-Infektion.

Über uns

Berliner niedergelassene Ärzte mit Schwerpunkt in der Versorgung von Menschen mit HIV und viralen Hepatitiden und die damalige Klinik für Innere Medizin / Infektiologie des Vivantes Auguste-Viktoria-Klinikums und aktuell des St. Joseph Krankenhauses haben sich zum Wissenschaftsunternehmen‚ EPIMED – Gesellschaft für epidemiologische und klinische Forschung in der Medizin mbH zusammengeschlossen, um ein gemeinsames Netzwerk zur Planung und Durchführung von wissenschaftlichen Vorhaben und klinischen Studien aufzubauen.

Das Konzept von EPIMED ist das einer Independent Clinical Research Facility; die Verknüpfung von guter (haus)ärztlicher Versorgung einerseits und hervorragender Qualität der in den klinischen Prüfungen erhobenen Daten andererseits, die wir bei der Durchführung von Phase I-III Studien gewährleisten. Mit über 140 Studien in 20 Jahren können wir nicht ohne Stolz darauf verweisen, an vielen entscheidenden Entwicklungen von Substanzen, insbesondere in der ART-Forschung, mitgewirkt zu haben.

EPIMED versteht sich darüber hinaus als selbstverständlicher Teil des Berliner „Schöneberger Model“, das mit Beginn der AIDS-Pandemie richtungweisend Kliniken und niedergelassene Ärzte, Forschung und Versorgung, Prävention und Behandlung, AIDS-Hilfen und Pflege miteinander verbindet.

Lesen Sie bitte mehr zu unserem Know-How, zu unserer Struktur und Ausstattung und zu unseren Angeboten im Menü Für Sponsoren.

 

Team Studienzentrale

Dr. med. Christina Sophie Engelhard

Seit Juni 2020 Teamleitung und als medical clinical studies research manager verantwortlich für die generellen, organisatorischen Abläufe in der Studiendurchführung, sowie Ansprechpartnerin für Sponsoren und Kollegen in den peripheren Einheiten. Sie ist ausgebildete Fachärztin für Innere Medizin und stieß im Januar 2019 zum EPIMED-Team, nachdem Sie seit 2014 als Assistenzärztin im Helios Klinikum Berlin Buch in den Bereichen Hämatologie, Onkologie, Tumorimmunologie, Stammzellentransplantation und Intensivmedizin gearbeitet hatte. In enger Zusammenarbeit mit dem Hauptprüfer Dr. Arastéh liegt Ihr Schwerpunkt als Prüfärztin der EPIMED-Zentrale in der Beurteilung neu eingereichter Studien-Protokolle, der Überprüfung der source-data und der Rücksprache mit den Schwerpunktärzten, Sponsoren und CROs. Sie führt Patientenaufklärungen und Screening-Visiten durch, bewertet Laborbefunde und SUA-Reports.

 
Michael Rittweger

Facharzt für Innere Medizin und stellvertretender Prüfer, kam im Jahr 2004 zu EPIMED. Er ist ist heute neben seiner Tätigkeit für EPIMED, niedergelassener Arzt in der praxiswilmersdorfer in Berlin. Er hat seit 2002 zahlreiche klinische Studien inner- und außerhalb von EPIMED betreut.

Josephine Fink

ist seit September 2020 Study-Coordinator bei EPIMED. Sie ist ausgebildete MFA und arbeitete zuvor in einigen Hausarztpraxen, zuletzt war sie in der Kantpraxis mit rheumatologischen und gastroenterologischem Schwerpunkt. Sie betreut eigene Studien beginnend bei der Konzeption und gesamten Durchführung. Mit ihrer äußerst schnellen Auffassungsgabe optimiert sie zudem viel interne Prozesse.

 


Meltema Friedrich

ist seit März 2020 Study-Coordinator bei EPIMED. Sie ist examinierte Krankenpflegerin und arbeitete zuvor als Studienkoordinatorin in der gynäkologischen Klinik der Charité, Campus Virchow. Sie ist verantwortlich für die Visitenplanung zahlreicher Studien, für die Erstellung von Worksheets, für Labor- und Medikamentenlogistik, für Visitendokumentation und Eingabe und Pflege von Studiendaten.

 
Sophia Charlotte Garoes

Study coordinator …..

Dietmar Schranz

ist seit 1999 Geschäftsführer der EPIMED GmbH und als niedergelassener Arzt einer Schwerpunktpraxis in Berlin-Charlottenburg von Anfang an beteiligt an EPIMED-Studien. Seine Führungs- und Planungsaufgaben umfassen die Überprüfung der Verantwortbarkeit und Machbarkeit von Studienangeboten und die Leitung der regelmäßigen Studienbesprechungen der beteiligten EPIMED-Studienärzte.

Priv. Doz. Dr. Keikawus Arastéh,

Prüfer, ist zusammen mit Dietmar Schranz Geschäftsführer der EPIMED GmbH mit Schwerpunkt auf der Akquise von Studien. In seiner Funktion obliegt ihm die Gesamtverantwortung über alle Prüfungen bei EPIMED. Seit 1991 führt er Studien im Bereich HIV/AIDS und angrenzenden Indikationsfeldern durch, hat dazu in zahlreichen Fachzeitschriften publiziert und ist Mitautor der Deutsch-Österreichischen Leitlinien zur antiretroviralen Therapie der HIV-Infektion.

Für Ärzte

Dietmar Schranz

 

Sehr geehrte Kollegin, sehr geehrter Kollege,

Sie sind im Berliner Raum niedergelassene/r Ärztin/Arzt und behandeln Patienten in den Indikation HIV/Hepatitiden, angrenzenden internistischen und infektiologischen Indikation wie STD oder Sie sind auch an neuartigen Schutzimpfungen interessiert und möchten an klinischen Studien teilhaben? Sei es, weil Ihre Patienten neue Therapieoptionen brauchen, oder weil Sie klinische Forschung notwendig und interessant finden?

Als regionales Prüfzentrum mit über zwanzigjähriger Erfahrung bieten wir Ihnen das know-how und die Infrastruktur dafür. Wir arbeiten erfolgreich mit den großen pharmazeutischen Herstellern, wie auch vielen unabhängigen Forschungsinstituten und können von erstklassiger Patientenbetreuung bis zur Vorstellung der Studienergebnisse auf wissenschaftlichen Konferenzen die ganze Bandbreite klinischer Studien ausfüllen.

Um die Anbindung von qualitativ hochwertiger hausärztlicher Versorgung und Studiendurchführung zu gewährleisten, freuen wir uns über die Kooperation mit den niedergelassenen Ärzten.  Auf unseren regelmäßigen Meetings bringen wir dazu nicht nur Information zu neuen Studien, sondern diskutieren auch das für und wieder neuer Substanzen. Wenn Sie Interesse an einer Mitarbeit bei EPIMED haben, lade ich Sie ein mit uns Kontakt aufzunehmen.

Bitte informieren Sie sich auf dieser website auch in den Menüs Studien, Über uns und Sponsoren über das gesamte Spektrum unserer Aktivitäten.

Dietmar Schranz, Facharzt für Innere Medizin

Letzte Änderung: 21.02.2018

Publikationen (Auswahl)

The Role of Abacavir (ABC, 1592) in Antiretroviral Therapy-Experienced Patients: Preliminary 48-Week Results from a Randomized Double-Blind Trial. Katlama C, Clotet B,  Plettenberg A, Jost J, Arastéh K, Bernasconi E, Jeantils V, Cutrell A, Purdon S, Stone C, Ait-Khaled M; Interscience Conference on Antimicrobial Agents and Chemotherapy. NCBI PubMed AIDS. 2000 May 5;14(7):781-9.

GW420867X administered to HIV-1-infected patients alone and in combination with lamivudine and zidovudine. K Arasteh, R Wood, M Müller, W Prince, L Cass, KH Moore, N Dallow, A Jones, A Klein, V Burt, JP Kleim. HIV clinical trials 2001 Jul-Aug.

Enfurvirtide in combination with an optimized backgraound regimen vs OB alone: week 24 response among categories of baseline demographics, treatmentexperience, and HIV antiretroviral resistance. J Lange, A Lazzarin, B Clotet, D Cooper, J Reynes, K  Arastéh. Int Cong Drug Therapy Hv 2002 Nov 17-21;6:Abstract No. PL14.3.

An Open-Label Assessment of TMC 125 – A New, Next-Generation NNRTI, for 7 Days in HIV-1 Infected Individuals With NNRTI Resistance. Brian G. Gazzard; Anton L. Pozniak; Willy Rosenbaum; G. Patrick Yeni; Schlomo Staszewski; Keikawus Arastéh; Karin De Dier; Monika Peeters; Brian Woodfall; Justin Stebbing; Gerben A. E. vant’ Klooster. AIDS 17(18):F49-F54, 2003.

Correlation of Viral Load Reduction and Plasma Levels in Multiple Protease Inhibitor Experienced Patients Taking Tipranavir/Ritonavir in a Phase IIB Trial: BI 1182.52. Yeni P, MacGregor T, Gathe J, Arastéh K, Jayaweera D, Jemsek J, Hawkins T, Cameron W, Bodsworth N, McCallister S, Kohlbrenner V, Quinson A, Leith J, Sabo J, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Feb 10 14 2003 Hynes Conv Cent Boston Mass USA Conf Retrovir Oppor Infect 10th 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 528.

Enfuvirtide TORO Studies: 48-Week Results Confirm 24-Week Findings. C. Katlama, K. Arastéh, B. Clotet, D.Cooper, K. Henry, J. Lalezari, A. Lazzarin, J. Montaner, M. Nelson, M. O’Hearn, P. Piliero, J. Reynes, B. Trottier, S. Walmsley, R. DeMasi, J. Delehanty, J. Chung, M. Salgo. 2nd IAS Conference on HIV Pathogenesis and Treatment: Paris, France, July 13-16, 2003

The Effects of Enfuvirtide Therapy on Body Composition and Serum Lipids through 48 Weeks in the TORO Trials. Cooper D, Reiss P, Henry K, Nelson M, O’Hearn M, Piliero P, Reynes J, Arastéh K, Chung J, Guimaraes D, Kinchelow T, Bertasso A; the TORO 1 and TORO 2 study groups; Conference on Retroviruses and Opportunistic Infections (11th : 2004 : San Francisco, Calif.). Program Abstr Conf Retrovir Oppor Infect 11th 2004 San Franc Calif. 2004 Feb 8-11; 11: abstract no. 715

TORO: 96 week virological and immunological response and safety evaluation of enfuvirtide with an optimized background regimen. Arastéh K, Lazzarin A, Clotet B, Lalezari J, Cooper D, Henry K, O’Hearn M, Reynes J, Piliero P, Trottier B, Montaner J, Walmsley S, Nelson M, Katlama C, Chung J, DeMasi R, Guimaraes D, Huson L, Donatacci L, Wat C, Kinchelow T, Bertasso A, Miralles GD, Salgo M. Int Conf AIDS. 2004 Jul 11-16; 15: abstract no. MoOrB1058.

Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. Lazzarin A, Clotet B, Cooper D, Reynes J, Arastéh K, Nelson M, Katlama C, Stellbrink HJ, Delfraissy JF, Lange J, Huson L, DeMasi R, Wat C, Delehanty J, Drobnes C, Salgo M; TORO 2 Study Group. N Engl J Med. 2003 May 29;348(22):2186-95.

Sustained Anti-HIV-1 Effect of Racivir Combined with D4T and Sustiva Following a 14-day Treatment of Infected Volunteers. Otto MJ, Arasteh K, Kreckel P, Drauz D, Beard A, Cartee L, Hurwitz SJ, Liotta DC, Schinazi RF, Murphy RL. Abstr 10th Conf Retrovir Oppor Infect 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 552.

Correlation of Viral Load Reduction and Plasma Levels in Multiple Protease Inhibitor Experienced Patients Taking Tipranavir/Ritonavir in a Phase IIB Trial: BI 1182.52. Yeni P, MacGregor T, Gathe J, Arastéh K, Jayaweera D, Jemsek J, Hawkins T, Cameron W, Bodsworth N, McCallister S, Kohlbrenner V, Quinson A, Leith J, Sabo J, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Feb 10 14 2003 Boston Mass. 2003 Feb 10-14; 10: abstract no. 528.

Tipranavir/Ritonavir Demonstrates Potent Efficacy in Multiple Protease Inhibitor Experienced Patients: BI 1182.52. Gathe J, Kohlbrenner VM, Pierone G, Arastéh K, Rubio R, LaLonde R, Piliero P, McCallister S, Garfinkel S, Chaves R, Mukwaya GM, Dohnanyi C, Shaw S, Drees U, Mayers D. Abstr 10th Conf Retrovir Oppor Infect Boston Mass. 2003 Feb 10-14; 10: abstract no. 179.

Nevirapine significantly reduces the levels of racemic methadone and (R)-methadone in human immunodeficiency virus-infected patients. Stocker H, Kruse G, Kreckel P, Herzmann C, Arasteh K, Claus J, Jessen H, Cordes C, Hintsche B, Schlote F, Schneider L, Kurowski M. Antimicrobial Agents and Chemotherapy, Nov 2004, p. 4148-4153, Vol. 48, No. 11.

Six-week randomized controlled trial to compare the tolerabilities, pharmacokinetics, and antiviral activities of GW433908 and amprenavir in human immunodeficiency virus type 1-infected patients. Wood R, Arastéh K, Stellbrink HJ, Teofilo E, Raffi F, Pollard RB, Eron J, Yeo J, Millard J, Wire MB, Naderer OJ.Antimicrobial Agents and Chemotherapy, Jan 2004, p. 116-23, Vol. 48 No.1.

A 42-Week Open-Label Study to Assess the Pharmacokinetics, Antiretroviral Activity, and Safety of Amprenavir or Amprenavir plus Ritonavir in Combination with Abacavir and Lamivudine for Treatment of HIV-Infected Patients. Robin Wood, Joseph Eron, Keikawus Arastéh,  Eugenio Teofilo, Christian Trepo, Jean-Michel Livrozet, Jane Yeo, Judith Millard, Mary Beth Wire and Odin J. Naderer. Clinical Infectious Diseases 2004;39:591–594.

Safety, Pharmacokinetics, and Efficacy of (+/–)-ß-2′,3′-Dideoxy-5-Fluoro-3′-Thiacytidine with Efavirenz and Stavudine in Antiretroviral-Naïve Human Immunodeficiency Virus-Infected Patients. C. Herzmann, K. Arastéh, R. L. Murphy, H. Schulbin, P. Kreckel, D. Drauz, R. F. Schinazi, A. Beard, L. Cartee, and M. J. Otto.Antimicrobial Agents and Chemotherapy, Jul 2005, p. 2828-33, Vol. 49, No.7.

TMC114/ritonavir substitution for protease inhibitor(s) in a non-suppressive antiretroviral regimen: a 14-day proof-of-principle trial. Arastéh K, Clumeck N, Pozniak A, Lazzarin A, De Meyer S, Muller H, Peeters M, Rinehart A, Lefebvre E; TMC114-C207 Study Team. NCBI PubMed AIDS. 2005 Jun 10;19(9):943-7.

Six-Week Randomized Controlled Trial To Compare the Tolerabilities, Pharmacokinetics, and Antiviral Activities of GW433908 and Amprenavir in Human Immunodeficiency Virus Type 1-Infected Patients. Robin Wood, Keikawus Arastéh, Hans-Jürgen Stellbrink, Eugenio Teofilo, François Raffi, Richard B. Pollard, Joseph Eron, Jane Yeo, Judith Millard, Mary Beth Wire and Odin J. Naderer. Antimicrobial Agents and Chemotherapy Jan 2004, p 116-23, Vol. 48 No. 1.

Safety of Enfuvirtide in Combination With an Optimized Background of Antiretrovirals in Treatment-Experienced HIV-1-Infected Adults Over 48 Weeks. Benoit Trottier, MD; Sharon Walmsley, MD; Jacques Reynes, MD, PhD; Peter Piliero, MD; Mary O’Hearn, MD; Mark Nelson, MA, MBBS, MRCP; Julio Montaner, MD; Adriano Lazzarin, MD; Jacob Lalezari, MD; Christine Katlama, MD; Keith Henry, MD; David Cooper, MD, DSc; Bonaventura Clotet, MD, PhD; Keikawus Arastéh, MD; Jean-François Delfraissy, MD; Hans-Jürgen Stellbrink, MD; Joep Lange, MD, PhD; Daniel Kuritzkes, MD; Joseph J Eron, Jr MD; Calvin Cohen, MD, MSc; Tosca Kinchelow, MD; Anne Bertasso, BS; Emily Labriola-Tompkins, BA; Anna Shikhman, BSN, MBA; Belinda Atkins; Laurence Bourdeau, PhD; Christopher Natale, MSc; Fiona Hughes, BSc; Jain Chung, PhD; Denise Guimaraes, MS; Claude Drobnes, MD; Silvia Bader-Weder, MD; Ralph DeMasi, PhD; Lynn Smiley, MD; Miklos P Salgo, MD, PhD. Journal of Acquired Immune Defic Syndr. 2005;40(4):413-421.

Ritonavir-boosted tipranavir demonstrates superior efficacy to ritonavir-boosted protease inhibitors in treatment-experienced HIV-infected patients: 24-week results of the RESIST-2 trial. Cahn P, Villacian J, Lazzarin A, Katlama C, Grinsztejn B, Arastéh K, López P, Clumeck N, Gerstoft J, Stavrianeas N, Moreno S, Antunes F, Neubacher D, Mayers D. Clin Infect Dis. 2006 Nov 15;43(10):1347-56.

Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial.  Lazzarin A, Campbell T, Clotet B, Johnson M, Katlama C, Moll A, Towner W, Trottier B, Peeters M, Vingerhoets J, de Smedt G, Baeten B, Beets G, Sinha R, Woodfall B; DUET-2 study group. Lancet. 2007 Jul 7; 370(9581):39-48.

Efficacy and Safety of Three Doses of Tipranavir Boosted with Ritonavir in Treatment-ExperiencedHIV Type 1-Infected Patients. Joseph C. Gathe jr, Gerald Pierone, Peter Piliero, Keikawus Arastéh, Rafael Rubio, Richard G. Lalone, David Cooper, Adriano Lazzarin, Veronika M. Kohlbrenner, Catharine Dohnanyi, John Sabo and Douglas Mayers. AIDS Research and Human Retroviruses Vol. 23, No. 2, 2007, pp. 216–223.

Saquinavir, nelfinavir and M8 pharmacokinetics following combined saquinavir, ritonavir and nelfinavir administration. Stocker H, Herzmann C, Breske A, Kruse G, Berger M, Schulbin H, Hill A, Steinmüller J, Becker M, Arastéh K, Kurowski M. Journal of Antimicrobial Chemotherapy 2007; 59:560-4.

Pharmacokinetics, safety, and efficacy of tipranavir boosted with ritonavir alone or in combination with other boosted protease inhibitors as part of optimized combination antiretroviral therapy in highly treatment-experienced patients (BI Study 1182.51). Walmsley SL, Katlama C, Lazzarin A, Arestéh K, Pierone G, Blick G, Johnson M, Meier U, MacGregor TR, Leith JG. Journal of Acquirerd Immune Defic Syndr. 2008 Apr 1;47(4):429-40.

Switch from a ZDV/3TC-based regimen to a completely once daily (QD) regimen of emtricitabine/tenofovir DF fixed dose combination plus a third QD agent (SONETT). K. Arastéh, L. Weitner, S. Fenske, B. Kuhlmann, M. Freiwald, R. Ebrahimi, L. Gallo, B. Ranneberg, T. Mertenskoetter. Eur J Med Res (2009) 14:195-199.

Short-term randomized proof-of-principle trial of TMC278 in patients with HIV type-1 who have previously failed antiretroviral therapy. Keikawus Arastéh, Armin Rieger, Patrick Yeni, Anton Pozniak, Griet Boogaerts, Rolf van Heeswijk, Marie-Pierre P de Béthune, Monika Peeters, and Brian Woodfall. Antiviral Therapy 14(5):713 (2009) PMID 19704175

Prospective comparison of nevirapine and atazanavir/ritonavir both combined with tenofovir DF/ emtricitabine in treatment-naïve HIV-1 infected patients: ARTEN study week 48 results. V. Soriano, S. Köppe, H. Mingrone, T. Lutz, M. Opravil, J. Andrade-Villanuev. Lutz, M. Opravil, J. Andrade-Villanueva, F. Antunes, G. Di Perri, D. Podzamczer, S. Taylor, A. Horban, D. Duiculescu, L. de Rossi. Poster, 5th IAS Conference 2009

ASSESSMENT OF THE STEADY STATE PK PARAMETERS OF TWO EXTENDED RELEASE (XR) NEVIRAPINE (NVP) TABLETS 400 MG AND 300 MG QD COMPARED WITH IMMEDIATE RELEASE (IR) NVP TABLETS 200 MG BID IN HIV-1 INFECTED PATIENTS – THE ERVIR STUDY M. Battegay, K. Arasteh, A. Plettenberg, J. Bogner, N. Brockmeyer, O. Degen, F. Boue, J.M. Livrozet, E. Van-steenberge, C.L. Yong1, J. Wu, F.J. Mensa, L. Waldhauser, J. Steffgen, F. Berger, J. Stern, P. Robinson, A.M. Quinson. 49th ICAAC, San Francisco, USA, 2009

48 Wk Efficacy and Safety of Switching Virologically Stable HIV-1 Patients from Nevirapine IR 200 mg BID to Nevirapine XR 400 mg QD (TRANxITION)  K. ARASTEH, D. WARD, A. PLETTENBERG, JM. LIVROZET, A. WINSTON, C. CORDES, E. WANG, A. QUINSON. 10th International Congress on Drug Therapy in HIV Infection, Glasgow, November 7-11, 2010

Twenty-four-week efficacy and safety of switching virologically suppressed HIV-1-infected patients from nevirapine immediate release 200 mg twice daily to nevirapine extended release 400 mg once daily (TRANxITION). Arasteh K, Ward D, Plettenberg A, Livrozet JM, Orkin C, Cordes C, Guo J, Wang E, Yong CL, Robinson P, Quinson A. HIV Med. 2012 Apr;13(4):236-44. doi: 10.1111/j.1468-1293.2011.00969.x. Epub 2011 Dec

Efficacy of the protease inhibitor BI 201335, polymerase inhibitor BI 207127, and ribavirin in patients with chronic HCV infection. Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Müllhaupt B, Gane E, Schuchmann M, Lohse A, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Kukolj G, Nehmiz G, Haefner C, Boecher WO. Gastroenterology. 2011 Dec;141(6):2047-55; quiz e14. Epub 2011 Sep 16.

4 week therapy with the non-nucleosidic polymerase inhibitor BI 207127 in combination with peginterferon-alfa2A and ribavirin in treatment naïve and treatment experienced chronic HCV GT1 patients. Dominique Larrey, Ansgar Lohse, Victor de Ledinghen, Christian Trepo, Tilman Gerlach, Jean-Pierre Zarski, Albert Tran, Philippe Mathurin, Robert Thimme, Keikawus Arastéh, Christian Trautwein,  Andreas Cerny, Nektarios Dikopoulos, Marcus Schuch- mann, Markus H. Heim, Guido Gerken, Jerry Stern, Katherine Wu, Nasri Abdallah, Birgit Girlich, Joseph Scherer, Wulf Boecher, Frank Berger, Jürgen Steffgen. Gastroenterology. 2011 Dec;141(6):2047-55; quiz e14. Epub 2011 Sep 16.

The SOUND-C1 study: High sustained virologic response following interferon-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI201335, polymerase inhibitor BI207127, and ribavirin, followed by BI201335 and PegIFN/ribavirin Stefan Zeuzem, Tarik Asselah, Peter Angus, Jean Pierre Zarski, Dominique Larrey, Beat Müllhaupt, Ed Gane, Marcus Schuchmann, Ansgar Lohse, Stanislas Pol, Joseph Moussalli, Jean-P. Bronowicki, Stuart Roberts, Keikawus Arasteh, Fabien Zoulim, Jerry O. Stern, Federico Mensa, Gerhard Nehmiz, Carla Häfner, Wulf Otto Böcher. Poster, International Conference on Viral Hepatitis, March 26-27 2012

TRANxITION 144-week results: switching virologically stable HIV patients from immediate-release nevirapine (NVP IR) to extended-release NVP (XR) K Arastéh, M Drulak, J Guo, J Livrozet, C Orkin, A Quinson, D Ward. Journal of the International AIDS Society 2012, 15(Suppl 4):183

Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. Hodder S, Arasteh K, De Wet J, Gathe J, Gold J, Kumar P, Mohapi L, Short W, Crauwels H, Vanveggel S, Boven K. HIV Med. 2012 Aug;13(7):406-15. doi: 10.1111/j.1468-1293.2012.00991.x. Epub 2012 Mar 14.

Dolutegravir Treatment Response and Safety by Key Subgroups in Treatment Naive HIV Infected Individuals. Cynthia Brinson, Sharon Walmsley, Keikawus Arasteh, Miguel Gorgolas, Lothar Schneider, Clare Brennan, Keith Pappa, Steve Almond, Catherine Granier, Francois Raffi. 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA

STARTVerso 4: High rates of early virologic response in HCV genotype 1/HIV-coinfected patients treated with faldaprevir plus PegIFN and RBV Douglas Dieterich, Vicente Soriano,2 Mark Nelson, Jürgen Kurt Rockstroh, Keikawus Arastéh, Sanjay Bhagani,Andrew Talal, Cristina Tural, Richard Vinisko, and Jens Kort, 20th Conference on Retroviruses and Opportunistic Infections, March 3–6, 2013

Cobicistat Versus Ritonavir as a Pharmacoenhancer of Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV Type 1–Infected Patients: Week 48 Results Joel E. Gallant,  Ellen Koenig,  Jaime Andrade-Villanueva, Ploenchan Chetchotisakd6, Edwin DeJesus, Francisco Antunes, Keikawus Arastéh, Graeme Moyle, Giuliano Rizzardini, Jan Fehr, Yapei Liu, Lijie Zhong, Christian Callebaut, Javier Szwarcberg, Martin S. Rhee and Andrew K. Cheng,  Journal of Infectious Diseases 208(1):32-39. July 1, 2013

STARTVerso 3: A randomized, double-blind, placebo-controlled Phase III trial of faldaprevir in combination with pegylated interferon alfa-2a and ribavirin in treatment-experienced patients with chronic hepatitis C genotype-1 infection Jacobson, Asselah, Ferenci, Foster, Jensen, Negro, Mantry, Wright, Forns, Garcia-Samaniego, Oliveira, Carvalho, Forton, Arastéh, Cooper, Ghesquiere, Dufour, Sakai, Tanaka, Stern, Sha, Boecher, Steinmann, Quinson, on behalf of the STARTVerso3 Study Group, American Association for the Study of the Liver: The Liver Meeting 2013. Poster Number 1100

STARTVerso 4 Phase III Trial of Faldaprevir Once-daily Plus Peg Interferon Alfa-2a and Ribavirin (PR) in Patients with HIV and HCV Genotype 1 Coinfection: End of Treatment Response (ETR) Jürgen Kurt Rockstroh, Mark Nelson, Vicente Soriano, Keikawus Arastéh, Josep Guardiola, Sanjay Bhagani, Josep Mallolas, Cristina Tural, Massimo Puoti, Patrick Ingiliz, Manuel Battega, Mamta K. Jain, Marina Nunez, Kristen Marks, Jens Kort, Jerry Stern, Richard Vinisko, Montserrat Manero, Douglas Dieterich, 14th European AIDS Conference (EACS), 16.-19. October 2013

TRANxITION 144 Week Results: Switching Virologically Stable HIV Patients From Immediate-Release Nevirapine (NVP IR) to Extended-Release NVP (XR) Keikawus Arasteh, Murray Drulak, Junhai Guo, Jean-Michel Livrozet, Chloe Orkin, Ann-Marie Quinson and Douglas Ward, J AIDS Clin Res 2014, 5:4

Antiviral Activity, Pharmacokinetics, and Safety of the HIV-1 Protease Inhibitor TMC310911, Coadministered With Ritonavir, in Treatment-Naive HIV-1–Infected Patients Stellbrink, Hans-Jürgen; Arastéh, Keikawus; Schürmann, Dirk; Stephan, Christoph; Dierynck, Inge; Smyej, Ilham; Hoetelmans, Richard M. W.; Truyers, Carla; Meyvisch, Paul ; Jacquemyn, Bert; Mariën, Kris; Simmen, Kenneth; Verloes, René;  JAIDS Journal of Acquired Immune Deficiency Syndromes:1 March 2014 – Volume 65 – Issue 3 – p 283–289

Faldaprevir Plus Pegylated Interferon α-2a/Ribavirin in HIV/HCV Co‑infection: STARTVerso4  Douglas Dieterich, Cristina Tural, Mark Nelson, Keikawus Arastéh, Vicente Soriano, Josep Guardiola, Sanjay Bhagani, Jürgen K Rockstroh, Jerry O Stern, Anne-Marie Quinson, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

Effect of Faldaprevir on Atazanavir Pharmacokinetics in Patients with HIV/HCV Co-Infection Mark Nelson, Keikawus Arastéh, Mamta K Jain, Vicente Soriano, José Valdez Madruga, Juvencio Furtado, Manuel Battegay, Fenglei Huang, Montserrat Manero, Douglas Dieterich, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

Safety and Antiviral Effect of MK-1439, a Novel NNRTI, (+Truvada®) in ART-Naive HIV Infected Patients J. O. Morales-Ramirez, J. M. Gatell, D. P. Hagins, M. Thompson, K. Arasteh, C. Hoffmann, C. Harvey, X. Xu, H. Teppler, The 2014 Conference on Retroviruses and Opportunistic Infections (CROI), March 3–6, 2014

SIMILAR ADJUSTED SVR12 RATES FOR HIV CO-INFECTED AND HCV MONO-INFECTED PATIENTS AND NO DOSE OR POPULATION (TREATMENT-NAÏVE/RELAPSER) EFFECT: POOLED ANALYSIS OF FALDAPREVIR PHASE III TRIALS Douglas Dieterich, Peter Ferenci, Ira M Jacobson, Francesco Negro, Massimo Puoti, Jürgen K Rockstroh, Michael P Manns, Keikawus Arastéh, Célia Oliveira, Jean-François Dufour, Elmar Zehnter, Clifford Leen, Sanjay Bhagani, Jerry O Stern, Anne-Marie Quinson, Joseph Scherer, Montserrat Manero, Donald M Jensen, 49th Annual Meeting of the European Association for the Study of the Liver (EASL), April 9–13, 2014

Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: A randomised placebo-controlled study Thomas Harrer, Andreas Plettenberg, Keikawus Arastéh, Jan Van Lunzen, Gerd Fätkenheuer, Hans Jaeger, Michel Janssens Wivine Burny, Alix Collard, François Roman, Alfred Loeliger, Marguerite Koutsoukos, Patricia Bourguignon, Ludo Lavreys, Gerald Voss. Vaccine,Volume 32, Issue 22, 7 May 2014, Pages 2657-2665

Simplification to Stribild vs Continuation of RTV-boosted DRV with FTC and TDF in Virologically Suppressed HIV Adults: A STRATEGY-PI Subgroup Analysis J Arribas, G Rizzardini, K Arastéh, C Zurawski, C Dietz, D Pontani, W Garner, and T Nguyen P273 HIV Drug Therapy, Nov 2-6 2014, Glasgow

Simplification to the STRIBILD single tablet regimen from PI plus RTV plus FTC/TDF multi-pill regimens maintains durable HIV suppression: Week 96 results of STRATEGY-PI (Study 115) K. Arastéh, H.J. Stellbrink, J.K. Rockstroh, A. Rieger, J. Arribas, E. DeJesus, C. Zurawski, M. Doroana, W. Towner, A. Lazzarin, M. Nelson, C. Müller, D. McColl, R. Swamy, T. Nguyen DÖAK 2015 24-27. Juni 2015, Düsseldorf, Germany

Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naive HIV-infected individuals in three randomized Trials. Raffi F, Rachlis A, Brinson C, Arasteh K, Górgolas M, Brennan C, Pappa K, Almond S, Granier C, Nichols WG, Cuffe RL, Eron J Jr, Walmsley S. AIDS. 2015 Jan 14;29(2):167-74.

Efficacy and Safety of Doravirine 100mg qd with TDF/FTC after 24 Weeks of Treatment in ART-Naive HIV-Infected Patients Jose M. Gatell, Francois Raffi, Andreas Plettenberg, Don Smith, Joaquin Portilla Sogorb, Christian Hoffmann, Keikawus Arasteh, Melanie Thompson, Debbie P. Hagins, Javier O. Morales-Ramirez, Xia Xu, Hedy Teppler.  AIDS 2015, Vancouver BC

Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection Stefan Bourgeois*, Hans Van Vlierberghe, Christophe Moreno, Hans Orlent, Frederik Nevens, Keikawus Arastéh, Yves Horsmans, Jörn M Schattenberg, Peter Buggisch, Sven Francque, Leen Vijgen, Thomas N Kakuda, Eva Hoeben, Donghan Luo, An Vandebosch, Bert Jacquemyn, Pieter Van Remoorter, Rene Verloes. Antiviral Therapy 2016

Doravirine 100 mg QD vs Efavirenz +TDF/FTC in ART- Naive HIV+ Patients: Week 48 Results. Jose M. Gatell; Francois Raffi; Andreas Plettenberg; Don Smith; Joaquin Portilla; Christian Hoffmann; Keikawus Arastéh; Melanie Thompson; Xia Xu; Hedy Teppler for the 1439-007 Study Team. Abstract #470 • CROI 2016, Boston MA, USA

 

     

Audits und Inspektionen

  • Inspektion zur Studie BI 1220.7, durchgeführt durch die US Food and Drug Administration (FDA), 31. März bis 3. April 2014
  • Studien-Audit zu Bionor Vacc-4x IMiD/-2010/1, veranlasst durch die CRO Aptiv Solutions, 7. und 8. November 2013
  • Studien-Audit zu A4001095, veranlasst durch den Sponsor Pfizer, 14. und 15. Mai 2013.
  • Studien-Audit zu GS-US-264-0106, veranlasst durch den Sponsor Gilead Sciences, 21. und 22. November 2011.
  • Studien-Audit zu ING114467, veranlasst durch den Sponsor GlaxoSmithKline, 12. und 13. Oktober 2011.
  • Studien-Audit zu BI 1100.1486, veranlasst durch den Sponsor Boehringer Ingelheim, 1. April 2009.
  • Inspektion zur Studie BI 1182.107, durchgeführt vom Landesamt für Gesundheit und Soziales, Berlin, Juni/Juli 2008.
  • Studien-Audit zu AI 424-138 (CASTLE), veranlasst durch den Sponsor Bristol-Myers-Squibb, November 2006.
  • GCP-Audit zur Studie WV16789, veranlasst durch den Sponsor ROCHE, Mai 2004.
  • Studien-Audit zu BI 1182.52, veranlasst durch den Sponsor Boehringer Ingelheim, Januar 2003.
  • GCP-Audit zur Studie APV 30005, veranlasst durch den Sponsor GlaxoSmithKline, Oktober 2002.

Letzte Änderung: 08.05.2014

Ausstattung

  • Ein Untersuchungszimmer mit EKGs
  • 8 Betten für Pharmakokinetik-Studienpatienten
  • EPIMED Notfall-Mobiltelefon für alle Patienten und peripheren Einheiten, 24 h erreichbar

Labor und Lagerung

  • Labor, ausgestattet mit zwei temperatur-kontrollierten Zentrifuge, Kühlschränken (4-8°C), Tiefkühlgeräten (-40°C und -70°C), Trockeneis, Arbeitsflächen für die Handhabung von Proben
  • Sicherer und temperaturkontrollierter Lagerraum für Studienmedikation
  • Sichereres und geräumiges Archiv für Studienakten

Extras

  • 3 Studienbüros, ausgestattet mit Hochleistungsscanner, Hochleistungs-Faxgerät, DSL und W-Lan für alle Mitarbeiter
  • Konferenzraum für 20 Personen
  • Separates Monitorbüro mit WLAN

Letzte Änderung: 13.05.2021

Kompetenz

  • Durchführung von jährlich ca. 20 EMA / FDA Studien, Phase Ib bis IIIb mit einer Gesamtzahl von 150 Patienten – HIV und HCV.
  • Teilnahme an der Entwicklung aller maßgeblichen ART seit 1997 und therapeutischer Impfstoffstudien seit 2009
  • Teilnahme an Protease / Polymerase Inhibitor Studien in der HCV Therapie seit 2008
  • GCP und in unseren Indikationsgebieten geschultes und erfahrenes Personal in der Zentrale und den peripheren Einheiten
  • Durchführung von GCP-Schulungen

Pre-Study

  • Professionelles Handling bei den Meldungen an die Ethikkommission
  • Sorgfältiges Pre-Screening aufgrund des Zugriffs auf die Original-Patientendaten
  • Gewissenhafte Aufklärung und qualifizierte Patientenbetreung

Study

  • Höchster Standard im jedem einzelnen Schritt der Studiendurchführung
  • 24-h-Betreung bei Pharmakokinetikstudien in der Immunologischen Tageklinik des Vivantes Auguste-Viktoria-Klinikums
  • Professioneller Umgang mit elektronischer Dokumentation (eCRF, z.b. InForm, Oracle)
  • Umfassende Betreuung des Monitorings

Post-Study

  • Sorgfältige Studiennachbereitung und sichere Archivierung

Letzte Änderung: 07.03.2016

Willkommen

Priv. Doz. Dr. K. Arastéh

Als 1997 die II. Klinik für Innere Medizin des Auguste-Viktoria-Krankenhauses zusammen mit niedergelassenen Schwerpunkt-Ärzten in der HIV-Versorgung EPIMED gründeten, um in Berlin ein gemeinsames Prüfzentrum für Studien zu ART und opportunistischen Infektionen zu ermöglichen, konnten wir noch nicht absehen, welches Erfolgsmodell damit angestoßen wurde. Heute können wir mit den über dreizehn zu EPIMED zusammengeschlossenen Praxen und Praxiszentren nicht nur auf eine langjährige Erfahrung in der Durchführung von multizentrischen Industrie-Studien der Phasen Ib bis IIIb, sondern auch auf zahlreiche investigator initiated trials und retrospektive Auswertungsstudien zurückblicken.

Auch haben wir im Laufe unserer Arbeit das Indikationsgebiet vom anfänglichen Schwerpunkt HIV und HIV-assoziierte Erkrankungen auf andere internistische und infektiologische Bereiche erweitert: Heute zählen Hepatitis C, andere virale Hepatitiden, Impfstudien sowie STDs dazu.

Dank unserer besonderen Prüfzentrumsstruktur können wir auf ein Pool von ca. 5.000 Patienten im Indikationsgebiet HIV/AIDS und ca. 1.000 Patienten im Indikationsgebiet virale Hepatiden zurückgreifen. Wir sind in der Lage, die Rekrutierungen für einzelne Studien qualitativ und quantitativ auf sehr hohem Niveau zu halten. Dieser optimale Ausgangspunkt, zusammen mit der Einrichtung eines zentralen Monitoring bei EPIMED trägt dazu bei, den Zeit- und Kostenaufwand für Forschung und Hersteller erheblich zu verringern.

Aus Gründen der Compliance oder wenn es ärztlich geboten ist, können Phase II/III-Studienpatienten nach Screening und Baseline in der Studienzentrale in der Klinik für Innere Medizin des Vivantes Auguste-Viktoria-Klinikums weitere Visiten in den peripheren Einheiten/Arztpraxen absolvieren. Unsere Standard Operation Procedures (SOP), die wir einer ständigen Qualitätskontrolle und Aktualisierung nach den Anforderungen von ICH-GCP, GCP-V und AMG unterwerfen, legen bis ins Detail die Arbeitsabläufe von der Screening-Visite bis zum SAE-Berichtswesen fest. Für Phase I / pharmakokinetische Studien, stehen Betten, eine 24h-Betreuung und die Notfallversorgung des Klinikums zur Verfügung.

Die Qualität unserer Arbeit wurde in 11 Audits durch unserer Auftraggeber oder von ihnen beauftragten Auditoren, lokalen Behörden und in der Inspektion der Food and Drug Administration (FDA) im Jahr 2014 bestätigt. Mit der Kompetenz des  EPIMED-Teams, der technischen Ausstattung unseres Prüfzentrums und der langjährigen Erfahrung können wir eine exzellente Qualität bei der Datenerhebung für die Forschung und für das Zulassungsverfahren garantieren. Nicht zuletzt stehen bei uns die Sicherheit, das Wohlergehen und die Wahrung der Rechte unserer Patienten immer im Mittelpunkt.

Wenn Sie mehr über uns erfahren möchten, benutzen Sie bitte unser Kontaktformular oder rufen Sie uns an. Für alle Ihre Fragen haben wir immer ein offenes Ohr.

Keikawus Arastéh

Letzte Änderung: 21.02.2018