Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: October 30, 2007
Last Update Posted: February 6, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to evaluate the virologic efficacy of vicriviroc combined with ritonavir-boosted Reyataz® in HIV-infected treatment-naïve subjects.
|HIV Infections||Drug: Vicriviroc Drug: emtricitabine and tenofovir disoproxil fumarate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Mean change from baseline in log10 HIV RNA [ Time Frame: Week 48 ]
Secondary Outcome Measures:
- Proportion of subjects with plasma HIV RNA <50 copies/mL [ Time Frame: Week 48 ]
|Study Start Date:||December 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Vicriviroc + Reyataz + ritonavir
vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
one 30 mg tablet QD
Other Name: SCH 417690; VCV
Active Comparator: Truvada® + Reyataz + ritonavir
Truvada® 200/300 combination tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD
Drug: emtricitabine and tenofovir disoproxil fumarate
one 200/300 combination tablet QD
Other Name: Truvada®, a combination of Emtriva® (emtricitabine 200 mg) and Viread® (tenofovir disoproxil fumarate 300 mg); emtricitabine + tenofovir DF; FTC + TDF
This is a randomized, open-label, active-controlled, parallel-group, multi-center study of vicriviroc maleate in treatment-naïve subjects infected with CCR5-tropic HIV. The study will compare the virologic benefit of vicriviroc combined with ritonavir-boosted Reyataz to a control group receiving Truvada plus ritonavir-boosted Reyataz. Interim analyses will be performed when the first cohort of 80 subjects have completed 24 weeks and 48 weeks of treatment. The second cohort of 120 subjects will be enrolled after the first interim analysis; a third interim analysis will be performed when subjects in this second cohort have completed 24 weeks of treatment. The primary efficacy analysis will be conducted when all 200 subjects from both stages have completed 48 weeks of treatment or discontinued. The final analysis will be performed at Week 96, when all 200 subjects have completed 96 weeks of treatment or discontinued. If vicriviroc is shown to provide benefit at the studied dose, study participants in the vicriviroc arm who complete 96 weeks of treatment may continue in a protocol extension, where they will be offered vicriviroc free of charge until the drug is commercially available in their location or until the sponsor terminates the clinical development of vicriviroc.
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