Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group study 359

This study compared antiretroviral activity among 6 "salvage" therapy regimens. The study was a prospective, randomized, 2 X 3 factorial, multicenter study of the AIDS Clinical Trials Group. The study enrolled 277 human immunodeficiency virus (HIV)-infected patients naive to nonnucleoside analogues who had taken indinavir >6 months. The patients had 2000-200,000 HIV RNA copies/mL, Patients received saquinavir with ritonavir or nelfinavir together with delavirdine and/or adefovir and were followed for safety and antiretroviral response between baseline and week 16, At week 16, 30% (77/254) of patients had less than or equal to 500 HIV RNA copies/mL, Virologic response did not differ significantly between pooled ritonavir and nelfinavir groups (28% vs. 33%; P = .50) or between pooled delavirdine and delavirdine/adefovir groups (40% vs. 33%; P = .42), Pooled delavirdine groups had a greater virologic response rate than did adefovir groups (40% vs. 18%; P = .002), Overall, one-third of patients who experienced virologic failure on an indinavir-containing regimen suppressed virus load levels while they were taking a new salvage regimen.