Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection

Martin S. Hirsch, Roy T. Steigbigel, Scholomo Staszewski, Deborah McMahon, Margaret A Fischl, Bernard Hirschel, Kathleen Squires, Mark J. DiNubile, Charlotte M. Harvey, Joshua Chen, Randi Y. Leavitt

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.

Original languageEnglish
Pages (from-to)1119-1124
Number of pages6
JournalClinical Infectious Diseases
Volume37
Issue number8
DOIs
StatePublished - Oct 15 2003

Fingerprint

Indinavir
Protease Inhibitors
HIV Infections
Lamivudine
Zidovudine
HIV
Safety
RNA
Nephrolithiasis
Intention to Treat Analysis
Hyperbilirubinemia
CD4 Lymphocyte Count
Drug-Related Side Effects and Adverse Reactions
Double-Blind Method
Nausea
Abdominal Pain
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Immunology

Cite this

Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection. / Hirsch, Martin S.; Steigbigel, Roy T.; Staszewski, Scholomo; McMahon, Deborah; Fischl, Margaret A; Hirschel, Bernard; Squires, Kathleen; DiNubile, Mark J.; Harvey, Charlotte M.; Chen, Joshua; Leavitt, Randi Y.

In: Clinical Infectious Diseases, Vol. 37, No. 8, 15.10.2003, p. 1119-1124.

Research output: Contribution to journalArticle

Hirsch, MS, Steigbigel, RT, Staszewski, S, McMahon, D, Fischl, MA, Hirschel, B, Squires, K, DiNubile, MJ, Harvey, CM, Chen, J & Leavitt, RY 2003, 'Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection', Clinical Infectious Diseases, vol. 37, no. 8, pp. 1119-1124. https://doi.org/10.1086/378063
Hirsch, Martin S. ; Steigbigel, Roy T. ; Staszewski, Scholomo ; McMahon, Deborah ; Fischl, Margaret A ; Hirschel, Bernard ; Squires, Kathleen ; DiNubile, Mark J. ; Harvey, Charlotte M. ; Chen, Joshua ; Leavitt, Randi Y. / Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection. In: Clinical Infectious Diseases. 2003 ; Vol. 37, No. 8. pp. 1119-1124.
@article{a0aa0f10557546fca94ced53657b48c1,
title = "Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection",
abstract = "A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34{\%}, according to a general estimating equation analysis, 92{\%}, according to an observed data analysis, and 24{\%}, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31{\%}, 85{\%}, and 22{\%}, respectively. Hyperbilirubinemia (experienced by 31{\%} of subjects), nausea (17{\%}), abdominal pain (14{\%}), and nephrolithiasis (13{\%}) were the most common drug-related adverse events during the extension.",
author = "Hirsch, {Martin S.} and Steigbigel, {Roy T.} and Scholomo Staszewski and Deborah McMahon and Fischl, {Margaret A} and Bernard Hirschel and Kathleen Squires and DiNubile, {Mark J.} and Harvey, {Charlotte M.} and Joshua Chen and Leavitt, {Randi Y.}",
year = "2003",
month = "10",
day = "15",
doi = "10.1086/378063",
language = "English",
volume = "37",
pages = "1119--1124",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "8",

}

TY - JOUR

T1 - Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection

AU - Hirsch, Martin S.

AU - Steigbigel, Roy T.

AU - Staszewski, Scholomo

AU - McMahon, Deborah

AU - Fischl, Margaret A

AU - Hirschel, Bernard

AU - Squires, Kathleen

AU - DiNubile, Mark J.

AU - Harvey, Charlotte M.

AU - Chen, Joshua

AU - Leavitt, Randi Y.

PY - 2003/10/15

Y1 - 2003/10/15

N2 - A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.

AB - A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.

UR - http://www.scopus.com/inward/record.url?scp=0142156151&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0142156151&partnerID=8YFLogxK

U2 - 10.1086/378063

DO - 10.1086/378063

M3 - Article

C2 - 14523778

AN - SCOPUS:0142156151

VL - 37

SP - 1119

EP - 1124

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 8

ER -