Therapy with Efavirenz plus Indinavir in Patients with Extensive Prior Nucleoside Reverse‐Transcriptase Inhibitor Experience: A Randomized, Double‐Blind, Placebo‐Controlled Trial Journal Articles uri icon

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  • 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 50 cells/mm(3), >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 <400 copies/mL in 68.2% of efavirenz versus 52.4% of placebo recipients (P=.004). CD4 cell count increases were 104+/-9 cells/mm(3) and 77+/-10 cells/mm(3) 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.


  • O'Byrne, Paul
  • Haas, David W
  • Fessel, W Jeffrey
  • Delapenha, Robert A
  • Kessler, Harold
  • Seekins, Daniel
  • Kaplan, Mark
  • Ruiz, Nancy M
  • Ploughman, Lynn M
  • Labriola, Dominic F
  • Manion, Douglas J

publication date

  • February 2001

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