title: A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease.
abstract: 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.
authors.affiliation: Department of Medicine, University of Miami School of Medicine, Miami, Florida 33101, USA. mfischl@med.miami.edu
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Fischl
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Ribaudo
authors.forename: Ann C
authors.initials: AC
authors.lastname: Collier
authors.forename: Alejo
authors.initials: A
authors.lastname: Erice
authors.forename: Marina
authors.initials: M
authors.lastname: Giuliano
authors.forename: Marjorie
authors.initials: M
authors.lastname: Dehlinger
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Michael S
authors.initials: MS
authors.lastname: Saag
authors.forename: Scott M
authors.initials: SM
authors.lastname: Hammer
authors.forename: Stefano
authors.initials: S
authors.lastname: Vella
authors.forename: Gene D
authors.initials: GD
authors.lastname: Morse
authors.forename: Judith E
authors.initials: JE
authors.lastname: Feinberg
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Demeter
authors.forename: Susan H
authors.initials: SH
authors.lastname: Eshleman
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D003521:Cyclopropanes; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage* / Q000627:therapeutic use; D010078:Oxazines / Q000008:administration & dosage* / Q000627:therapeutic use; D010349:Patient Compliance; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019469:Indinavir; D019888:Nelfinavir; C098320:efavirenz