A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease.
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.
Fischl
Margaret A
MA
Department of Medicine, University of Miami School of Medicine, Miami, Florida 33101, USA. mfischl@med.miami.edu
Ribaudo
Heather J
HJ
Collier
Ann C
AC
Erice
Alejo
A
Giuliano
Marina
M
Dehlinger
Marjorie
M
Eron
Joseph J
JJ
Saag
Michael S
MS
Hammer
Scott M
SM
Vella
Stefano
S
Morse
Gene D
GD
Feinberg
Judith E
JE
Demeter
Lisa M
LM
Eshleman
Susan H
SH
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
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