Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: A randomized, double-blind, placebo-controlled trial

A randomized, double-blind, placebo-controlled trial compared efavirenz (60 0 mg every 24 h) plus indinavir (1000 mg every 8 h) with placebo (every 24 h) plus indinavir (800 mg every 8 h) among 327 nucleoside analogue reverse- transcriptase inhibitor (NRTI)-experienced human immunodeficiency virus (HI V)-infected adults. Patients received less than or equal to2 concomitant NR TIs. Eligible patients had CD4 cell counts >50 cells/mm(3), >10,000 plasma HIV-1 RNA copies/mL, and no prior protease inhibitor or non-NRTI therapy. P atients had a mean of 2.8 years of prior NRTI therapy. At 24 weeks, plasma HIV-1 RNA level was <400 copies/mL in 68.2% of efavirenz versus 52.4% of pl acebo recipients (P = .004). CD4 cell count increases were 104 +/- 9 cells/ mm(3) and 77 +/- 10 cells/mm(3) in efavirenz and placebo recipients, respec tively (P = .023). Responses in efavirenz recipients were sustained at 48 w eeks. Thus, efavirenz plus indinavir with concomitant NRTIs is effective th erapy for NRTI-experienced patients.