Phase 4 trial compares LPV/r plus raltegravir versus LPV/r plus N(t)RTIs for HIV after first-line failure

Status: COMPLETED | Phase: PHASE4 Condition(s): HIV Infections Intervention(s): raltegravir (DRUG), 2N(t)RTI (DRUG), Ritonavir-boosted lopinavir (DRUG) The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir. The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks. The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks. Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life. Detailed: In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2N(t)RTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e., non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3N(t)RTIs. Eligible patients will be randomised to one of two arms: I. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTIs II. ritonavir boosted lopinavir (LPV/r) 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400 mg twice daily The primary objective of this study is to compare the virological efficacy of the two strategies as measured by the proportion of participants with HIV RNA Primary Outcome(s): Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization Enrollment: 558 (ACTUAL) Lead Sponsor: Kirby Institute Start: 2009-09 | Primary Completion: 2012-09 Results posted: 2014-01-17