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Abacavir-Lamivudine-Zidovudine vs Indinavir-Lamivudine-Zidovudine in Antiretroviral-Naive HIV-Infected Adults<SUBTITLE>A Randomized Equivalence Trial</SUBTITLE>

Staszewski, Schlomo·2001·JAMA

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Abstract

Context Abacavir, a nucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the role of abacavir in a triple nucleoside combination regimen has not been evaluated against a standard protease inhibitor-containing regimen for initial antiretroviral treatment. Objective To evaluate antiretroviral equivalence and safety of an abacavir-lamivudine-zidovudine regimen compared with an indinavir-lamivudine-zidovudine regimen. Design and setting A multicenter, phase 3, randomized, double-blind trial with an enrollment period from August 1997 to June 1998, with follow-up through 48 weeks at 73 clinical research units in the United States, Canada, Australia, and Europe. Patients Five hundred sixty-two antiretroviral-naive, HIV-infected adults with a plasma HIV RNA level of at least 10 000 copies/mL and a CD4 cell count of at least 100 x 10(6)/L. Interventions Patients were stratified by baseline HIV RNA level and randomly assigned to receive a combination tablet containing 150 mg of lamivudine and 300 mg of zidovudine twice daily plus either 300 mg of abacavir twice daily and indinavir placebo or 800 mg of indinavir every 8 hours daily plus abacavir placebo. After 16 weeks, patients with confirmed HIV RNA levels greater than 400 copies/mL were eligible to continue receiving randomized treatment or receive open-label therapy. Main outcome measure Virologic suppression, defined as HIV RNA concentration o…

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Authors: Staszewski, S.
Affiliations: Goethe University Frankfurt (DE)
Corresponding author: Staszewski, Schlomo
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2001-03-07
Volume: 285
Issue: 9
Pages: 1155
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.285.9.1155
OpenAlex: W2129710521
Cited by: 277
References: 38
Citations by year: 2026: 1 · 2023: 1 · 2022: 2 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 2 · 2016: 5 · 2015: 5 · 2014: 5 · 2013: 10 · 2012: 6
FWCI: 31.43
Type: journal article
Language: en
Open access: closed
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords: abacavir, indinavir, lamivudine, zidovudine, HIV infection, antiretroviral-naive patients, triple-drug combination therapy, nucleoside reverse transcriptase inhibitors, protease inhibitors, viral suppression, treatment safety, drug interactions, adverse events, CD4 count, HIV RNA
MeSH terms: Abacavir, Adult, Aged, Double-Blind Method, Drug Resistance, Microbial, Female, Genotype, HIV, Humans, Male, Middle Aged, Mutation, Therapeutic Equivalency, Zidovudine, Dideoxynucleosides, HIV Infections, Survival Analysis, HIV Protease Inhibitors, CD4 Lymphocyte Count, Reverse Transcriptase Inhibitors, Lamivudine, Anti-HIV Agents, Indinavir, Viral Load, Antiretroviral Therapy, Highly Active, HIV Reverse Transcriptase

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