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 ³5000 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

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 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 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.

TMC310911-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

2009

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.