Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Study P04100AM4)(COMPLETED)
The purpose of this study is to provide open-label vicriviroc to HIV treatment-experienced subjects who successfully completed 48 weeks of treatment on ACTG protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and subjects who screened for ACTG A5211 and met all inclusion and exclusion criteria, but were unable to enroll due to protocol closure. Vicriviroc will be administered in combination with an optimized background antiviral regimen, chosen by the investigator based on results of genotype and phenotype testing, the subject's history of prior antiretroviral drug use, and drug toxicity. OBT must include at least 3 antiviral drugs (not including vicriviroc), 1 of which is a ritonavir-boosted protease inhibitor.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211 (Protocol No. P04100)|
- Long-term safety and tolerability, including CD4/CD8 count, HIV RNA, vicriviroc drug-susceptibility testing, SAEs, new infections, AIDS-defining events, and changes in coreceptor tropism of HIV isolates. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Vicriviroc 30 mg QD
Vicriviroc 30 mg QD
Drug: Vicriviroc maleate
30 mg tablet for once daily oral administration until vicriviroc becomes commercially available.
Other Name: SCH 417690