A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease.

Academic Article


  • To compare long-term virologic benefits of antiretroviral regimens in persons with advanced human immunodeficiency virus (HIV) disease, a randomized, open-label study was conducted of 517 subjects with no or limited previous experience with antiretroviral therapy. Subjects received lamivudine plus zidovudine and indinavir (indinavir group), efavirenz plus indinavir (efavirenz + indinavir group), or nelfinavir plus indinavir (nelfinavir + indinavir group) and were monitored for 2.1 years. Virologic failure was lower in the efavirenz + indinavir group (P=.04) and higher in the nelfinavir + indinavir group (P=.006), compared with that in the indinavir group. No difference in grade 3 or 4 adverse event rates in the efavirenz + indinavir group (P=.97) and a trend toward an increased rate in the nelfinavir + indinavir group (P=.07), compared with the indinavir group, were noted. A 4-drug regimen containing efavirenz plus indinavir resulted in a superior virologic response, whereas one containing nelfinavir plus indinavir resulted in an inferior response and a greater likelihood of toxicity.
  • Published In


  • Adult, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, Drug Resistance, Viral, Female, HIV Infections, HIV-1, Humans, Indinavir, Male, Nelfinavir, Oxazines, Patient Compliance, RNA, Viral, Reverse Transcriptase Inhibitors, Treatment Outcome
  • Digital Object Identifier (doi)

    Author List

  • Fischl MA; Ribaudo HJ; Collier AC; Erice A; Giuliano M; Dehlinger M; Eron JJ; Saag MS; Hammer SM; Vella S
  • Start Page

  • 625
  • End Page

  • 634
  • Volume

  • 188
  • Issue

  • 5