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- Title
Vicriviroc in Combination Therapy with an Optimized Regimen for Treatment-Experienced Subjects: 48-Week Results of the VICTOR-E1 Phase 2 Trial.
- Authors
Suleiman, Jamal; Zingman, Barry S.; Diaz, Ricardo Sobhie; Madruga, Jose Valdez Ramalho; DeJesus, Edwin; Slim, Jihad; Mak, Carmen; Lee, Erin; McCarthy, Michael C.; Dunkle, Lisa M.; Walmsley, Sharon
- Abstract
Background. Agents that block the CCR5 coreceptor for human immunodeficiency virus (HIV) have demonstrated potent antiretroviral activity. In early clinical studies, the CCR5 antagonist vicriviroc proved to be a safe and effective component of combination antiretroviral therapy. Methods. This double-blind, dose-ranging, phase 2 trial randomized subjects to receive 30 mg or 20 mg of vicriviroc or placebo once daily plus re-optimized background therapy containing a protease inhibitor with ritonavir. Subjects were adults infected with CCR5-tropic HIV who were experiencing failure of triple antiretroviral regimens. The primary end point was mean change in baseline log10 HIV RNA level at 48 weeks, based on an intent-totreat analysis. Results. One hundred fourteen persons received vicriviroc at 30 mg (n=39), vicriviroc at 20 mg (n=40), or placebo (n=35). The mean change in baseline HIV RNA level at week 48 was -1.77 log10 copies/mL for 30 mg of vicriviroc and -1.75 log10 copies/mL for 20 mg of vicriviroc, compared with -0.79 log10 copies/mL for placebo (P=.002 and P=.003, respectively, compared with placebo). Mean CD4 counts increased by 102, 136, and 63 cells/mm3 for 30 mg vicriviroc, 20 mg vicriviroc, and placebo, respectively (Pp.260 and Pp.039, respectively, compared with placebo). Rates of adverse events (mostly mild-to-moderate) were 111.4, 112.5, and 147.4 events per 100 subject-years, respectively. Conclusions. Vicriviroc administered with a protease inhibitor plus ritonavir-containing regimen shows potent antiretroviral and immunologic activity sustained over 48 weeks in treatment-experienced patients.
- Subjects
HIV; CLINICAL trials; ANTIRETROVIRAL agents; PLACEBOS; PROTEASE inhibitors; RNA; CHEMOKINES; BLIND experiment; CLINICAL medicine research
- Publication
Journal of Infectious Diseases, 2010, Vol 201, Issue 4, p590
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1086/650342