ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results.

摘要: Objective: To evaluate the safety and antiviral activity of different dose levels HIV protease inhibitor ABT-378 combined with low-dose ritonavir, plus stavudine lamivudine in antiretroviral-naive individuals. Design: Prospective, randomized, double-blind, multicenter. Methods: Eligible patients plasma HIV-1 RNA > 5000 copies/ml received ART378 200 or 400 mg ritonavir 100 every 12 h; after 3 weeks 40 150 h were added (group I, n = 32). A second group initiated treatment II, 68). Results: Mean baseline was 4.9 logic both groups CD4 cell count 398 X 10 6 /l 310 Groups I II respectively, In intent-to-treat (ITT; missing value failure) analysis at 48 weeks, < for 91% (< 50 copies/ml, 75%) 82% (<50 79%) respectively. steady-state trough concentrations exceeded wild-type EC (effective concentration to inhibit 50%) by 50-100-fold. The most common adverse events abnormal stools, diarrhea nausea. No patient discontinued before because treatment-related toxicity virologic rebound. Conclusions: is a potent, well-tolerated inhibitor. durable suppression observed this study probably attributable tolerability profile achievement high concentrations.