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Safety of vicriviroc in antiretroviral-experienced patients: 12 week VICTOR-E1 results
Presented by Jihad Slim, United States.
Slim J.1, Sobhie Diaz R.2, DeJesus E.3, Suleiman J.4, Dunkle L.5, Alvarez D.5
1St. Michael's Medical Center- Infectious Diseases, Newark, United States, 2Laboratorio de Retrovirologia, Sao Paulo, Brazil, 3Orlando Immunology Center, Orlando, United States, 4Brazilmed Assistencia Medica e Pesquisa S/C Ltda, Sao Paulo, Brazil, 5Schering Plough Research Institute, Kenilworth, United States
Objectives: Vicriviroc is a small-molecule CCR5 antagonist in clinical development. VICTOR-E1 is a randomized, double-blind, placebo-controlled dose-finding study comparing once daily (QD) vicriviroc, at higher doses than studied before, vs placebo in combination with a ritonavir-boosted protease inhibitor (PI) containing optimized antiretroviral therapy (ART) regimen in antiretroviral-experienced patients with CCR5-tropic HIV-1. We will report the 12-week safety results.
Methods: Eligible patients were failing current stable antiretroviral therapy (ART) and were 3-class ART experienced, with genotypically documented NRTI and PI resistance. Subjects had HIV viral load >1,000 copies/mL, no CNS abnormalities, acceptable laboratory values, and R5-tropic only virus (Trofileä) at screening. Patients were randomized to receive vicriviroc 20mg, 30mg, or placebo and were prescribed an optimized background antiretroviral regimen that included a ritonavir-boosted PI. Patients were assessed for treatment emergent adverse events throughout treatment.
Results: 116 subjects were enrolled at 60 sites in 12 countries between June and November 2006. Mean age at enrollment was 45.5 years, and 24% were women. Mean baseline viral load and CD4 count were 5.2 log10 copies/ml and 219 cells/mm3, respectively. Trofileä change from R5 to D/M occurred in 6 subjects between screening and Day 1 (prior to study drug). Mean duration of treatment was ~14 weeks (range 12-28). The blinded review of safety data shows no safety concerns, specifically no hepatotoxicity, malignancies, or drug-related seizures. Unblinded data are being reviewed by an independent DSMB.
Conclusions: Vicriviroc 20mg and 30mg administered once daily in combination with a ritonavir-boosted PI containing ART regimen appears to be well tolerated in this treatment-experienced population.
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