Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5)
|HIV Infections Acquired Immunodeficiency Syndrome||Drug: Vicriviroc Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E3)|
- Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL) [ Time Frame: 48 weeks ]
- Mean change from baseline in plasma HIV-1 RNA (log10 copies/mL); Proportion of subjects with <400 copies/mL of plasma HIV-1 RNA; Proportion of subjects with >=2log10 reduction from baseline in plasma HIV-1 RNA [ Time Frame: 48 weeks ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Test Arm
Vicriviroc 30 mg QD
One tablet of vicriviroc 30 mg once daily.
Other Name: SCH 417690
Placebo Comparator: Placebo Control Arm
One tablet of placebo once daily.
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects infected with CCR5-tropic virus only 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 two PIs (excluding low-dose ritonavir)and failed at least one standard triple-drug 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. OBT must include a PI boosted by ritonavir (>=100 mg ritonavir), and at least 2 active drugs (ie, to which HIV isolate is fully susceptible). 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. After completing Week 48 of the study, subjects who meet applicable criteria will be offered open-label vicriviroc 30 mg QD, if appropriate until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study.
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