EPIMED GmbH
Rubensstraße 125
12157 Berlin, Germany
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FAX: +49 30 130 20 2005
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Current Studies


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.


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.


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.


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.
(Phase I Studie zur Sicherheit und Reaktogenität des HIV-lmpfstoffs 732461 bei HIV-infizierten Patienien im Alter von 18-55 Jahren.)


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.
(Eine randomisierte, doppelblinde, multizentrische Phase-II-Immunogenitätsstudie zu Vacc-4x versus Placebo bei HIV-1-infizierten Patienten, die ein anhaltendes adäquates Ansprechen auf ART gezeigt haben.)


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.
(Pilotstudie zu einer neuen Kombinationstherapie aus Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/
Ritonavir + Emtricitabin/Tenofovir bei der Behandlung nicht vorbehandelter Patienten mit einer R5 HIV-1-Infektion.)


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.


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.

 

A5271022

A Phase 2b Multicenter, Randomized, Comparative Trial OF UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir  and a Nucleotide /Nucleoside Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With  Evidence Of NNRTI Resistant HIV-1.
EudraCT No.2007-004392-19.
(Multizentrische, randomisierte Studie der Phase II B zum Vergleich von UK-453,061 vs. Etravirin in Kombination mit Darunavir/Ritonavir und einem nukleosidalen Reverse-Transkriptase-Inhibitor (NRTI) in der Behandlung von antiretroviral vorbehandelten Patienten mit HIV-1-Infektion bei nachgewiesener Resistenz auf vorausgehende  NNRTI-Therapie) 

 

START

Strategischer Einsatz der antiretroviralen Therapie (ART). Einfluss einer frühen (CD4<500/mikrol) ART versus einer verzögerten CD4<350/mikrol) ART auf schwerwiegende AIDS definierende und nicht-AIDS definierende Erkrankungen. Strategic Timing of AntiRetroviral Treatment (START) EudraCT-No. 2008-006439-12


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

BI 1241.21

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

 

GILEAD 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

 

 

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Last change: 07/21/2010