DRV/r + RPV QD: Efficacy and Toxicity Reduction

Pilot, phase III prospective, randomized, open-label, multicentric controlled study, which will offer a novel dual-therapy regimen including RPV 25mg + DRV 800mg/rtv 100mg QD to HIV+ subjects with suppressed viremia. 132 HIV+ subjects will be randomized, 1:1, to switch to RPV+DRV/r versus continue triple-drug therapy. Subjects will be switched from any PI/r-containing regimen. The duration of the study is 96 weeks and patients will be stratified according to their HCV serostatus (Ab positive or negative), age (\> or \< 50 years), and immunological status (CD4\<200/µL; CD4=200-500/µL; CD4\>500/µL). It is planned to enroll at least 30% of female subjects. Follow-up visits will be performed at 4, 8, 12, 24, 36, 48, 60, 72, and 96 weeks (laboratory and physical examination). Effectiveness will be measured by determination of HIV-RNA, safety will be evaluated by determination of AST, ALT, creatinine, plasmatic and urinary phosphate, albuminuria, total cholesterol, HDL and LDL cholesterol, triglycerides at the follow-up visits.