HIV Infections Clinical Trial
Official title:
Vicriviroc in Combination Treatment With an Optimized ART Regimen in Treatment-Experienced Subjects With R5/X4 HIV Infection (VICTOR-E2; Protocol No. P05057)
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 investigate in
subjects with detectable dual/mixed CCR5/CXCR4-tropic HIV whether vicriviroc when added to
other appropriate HIV drugs can decrease the level of HIV (viral load) in the blood and that
it is well tolerated.
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study
of vicriviroc maleate in HIV subjects infected with dual/mixed CCR5/CXCR4-tropic virus and
who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI,
NNRTI or PI) or at least 6 months experience with at least 2 of the following: one NRTI, one
NNRTI, or one PI (excluding low-dose ritonavir) and failure on their current stable regimen.
The study will compare the virologic benefit of adding vicriviroc to an optimized background
regimen to a control group receiving placebo plus the new optimized background therapy. The
optimized background regimen will be chosen by the investigator based on results of drug
susceptibility tests performed at Screening, history of prior antiretroviral drug use by the
patient, and drug toxicity. Primary efficacy analysis will be conducted when all subjects
have completed 48 weeks of treatment. An interim analysis will be performed when all
subjects have completed 24 weeks of treatment. Subjects who complete 48 weeks of treatment,
or who discontinue early but are deemed eligible upon rescreening, will be offered
participation in the open-label segment of the study, and will receive vicriviroc 30 mg once
daily, if appropriate, until commercially available or until the sponsor terminates the
clinical development of vicriviroc.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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