Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875)
NCT00551018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2015-02-06
Summary
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
Vicriviroc
one 30 mg tablet QD
- DRUG
-
emtricitabine and tenofovir disoproxil fumarate
one 200/300 combination tablet QD
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2010-05-31
- Completion
- 2010-10-31
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