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

Margaret A Fischl, Heather J. Ribaudo, Ann C. Collier, Alejo Erice, Marina Giuliano, Marjorie Dehlinger, Joseph J. Eron, Michael S. Saag, Scott M. Hammer, Stefano Vella, Gene D. Morse, Judith E. Feinberg

Research output: Contribution to journalArticle

66 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)625-634
Number of pages10
JournalJournal of Infectious Diseases
Volume188
Issue number5
DOIs
StatePublished - Sep 1 2003

Fingerprint

Indinavir
Virus Diseases
efavirenz
HIV
Nelfinavir
Pharmaceutical Preparations
Lamivudine
Zidovudine

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease. / Fischl, Margaret A; Ribaudo, Heather J.; Collier, Ann C.; Erice, Alejo; Giuliano, Marina; Dehlinger, Marjorie; Eron, Joseph J.; Saag, Michael S.; Hammer, Scott M.; Vella, Stefano; Morse, Gene D.; Feinberg, Judith E.

In: Journal of Infectious Diseases, Vol. 188, No. 5, 01.09.2003, p. 625-634.

Research output: Contribution to journalArticle

Fischl, MA, Ribaudo, HJ, Collier, AC, Erice, A, Giuliano, M, Dehlinger, M, Eron, JJ, Saag, MS, Hammer, SM, Vella, S, Morse, GD & Feinberg, JE 2003, 'A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease', Journal of Infectious Diseases, vol. 188, no. 5, pp. 625-634. https://doi.org/10.1086/377311
Fischl, Margaret A ; Ribaudo, Heather J. ; Collier, Ann C. ; Erice, Alejo ; Giuliano, Marina ; Dehlinger, Marjorie ; Eron, Joseph J. ; Saag, Michael S. ; Hammer, Scott M. ; Vella, Stefano ; Morse, Gene D. ; Feinberg, Judith E. / A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease. In: Journal of Infectious Diseases. 2003 ; Vol. 188, No. 5. pp. 625-634.
@article{72b1cdeb5f6f48629974eb3933463b25,
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.",
author = "Fischl, {Margaret A} and Ribaudo, {Heather J.} and Collier, {Ann C.} and Alejo Erice and Marina Giuliano and Marjorie Dehlinger and Eron, {Joseph J.} and Saag, {Michael S.} and Hammer, {Scott M.} and Stefano Vella and Morse, {Gene D.} and Feinberg, {Judith E.}",
year = "2003",
month = "9",
day = "1",
doi = "10.1086/377311",
language = "English",
volume = "188",
pages = "625--634",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease

AU - Fischl, Margaret A

AU - Ribaudo, Heather J.

AU - Collier, Ann C.

AU - Erice, Alejo

AU - Giuliano, Marina

AU - Dehlinger, Marjorie

AU - Eron, Joseph J.

AU - Saag, Michael S.

AU - Hammer, Scott M.

AU - Vella, Stefano

AU - Morse, Gene D.

AU - Feinberg, Judith E.

PY - 2003/9/1

Y1 - 2003/9/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0141612909&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0141612909&partnerID=8YFLogxK

U2 - 10.1086/377311

DO - 10.1086/377311

M3 - Article

C2 - 12934177

AN - SCOPUS:0141612909

VL - 188

SP - 625

EP - 634

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 5

ER -