Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED)
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
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 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.