Dragsted, Ulrik BakGerstoft, JanPedersen, CourtPeters, BarryDuran, AdrianaObel, NielsCastagna, AntonellaCahn, PedroClumeck, NathanBruun, Johan NBenetucci, JorgeHill, AndrewCassetti, IsabelVernazza, PietroYoule, MikeFox, ZoeMaxCmin1 Trial Group2024-05-232024-05-232003-09-01https://doi.org/10.1086/377288https://repositorio.huesped.org.ar/handle/123456789/1363Fil: Cahn P. Fundación Huésped, Buenos Aires; ArgentinaThis trial assessed the rate of virological failure at 48 weeks in adult human immunodeficiency virus (HIV) type 1–infected patients assigned indinavir/ritonavir (Idv/Rtv; 800/100 mg 2 times daily) or saquinavir/ritonavir (Sqv/Rtv; 1000/100 mg 2 times daily) in an open-label, randomized (1:1), multicenter, phase 4 design. Three hundred six patients began the assigned treatment. At 48 weeks, virological failure was seen in 43 (27%) of 158 and 37 (25%) of 148 patients in the Idv/Rtv and Sqv/Rtv arms, respectively. The time to virological failure did not differ between study arms (P=.76). When switching from randomized treatment was counted as failure, this was seen in 78 of 158 patients in the Idv/Rtv arm, versus 51 of 148 patients in the Sqv/Rtv arm (P=.009). A switch from the randomized treatment occurred in 64 (41%) of 158 patients in the Idv/Rtv arm, versus 40 (27%) of 148 patients in the Sqv/Rtv arm (P=.013). Sixty-four percent of the switches occurred because of adverse events. A greater number of treatment-limiting adverse events were observed in the Idv/Rtv arm, relative to the Sqv/Rtv arm. In conclusion, Rtv-boosed Sqv and Idv were found to have comparable antiretroviral effects in the doses studiedapplication/pdfopenAccessClinical TrialHIV-1Articulo