Therapy with Efavirenz plus Indinavir in Patients with Extensive Prior Nucleoside Reverse‐Transcriptase Inhibitor Experience: A Randomized, Double‐Blind, Placebo‐Controlled Trial
Open Access
- 1 February 2001
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 183 (3) , 392-400
- https://doi.org/10.1086/318083
Abstract
A randomized, double-blind, placebo-controlled trial compared efavirenz (600 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 (HIV)—infected adults. Patients received ⩽2 concomitant NRTIs. Eligible patients had CD4 cell counts >50 cells/mm3, >10,000 plasma HIV-1 RNA copies/mL, and no prior protease inhibitor or non-NRTI therapy. Patients had a mean of 2.8 years of prior NRTI therapy. At 24 weeks, plasma HIV-1 RNA level was P = .004). CD4 cell count increases were 104 ± 9 cells/mm3 and 77 ± 10 cells/mm3 in efavirenz and placebo recipients, respectively (P = .023). Responses in efavirenz recipients were sustained at 48 weeks. Thus, efavirenz plus indinavir with concomitant NRTIs is effective therapy for NRTI-experienced patients.Keywords
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