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Efficacy and Safety of Twice-Daily versus Three-Times Daily Saquinavir Soft Gelatin Capsules as Part of Triple Combination Therapy for HIV-1 Infection
Journal article   Open access   Peer reviewed

Efficacy and Safety of Twice-Daily versus Three-Times Daily Saquinavir Soft Gelatin Capsules as Part of Triple Combination Therapy for HIV-1 Infection

L Joseph Wheat, Charles Farthing, Calvin Cohen, Gerald Pierone, Jay Lalezari, Robert S Pilson, Peggy Siemon-Hryczyk, John Baxter, Victor Beer, Nicholas C Bellos, …
Antiviral therapy, v 7(3), pp 199-209
01 Sep 2002
DOI: https://doi.org/10.1177/135965350200700310
PMID: 12487388
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1177/135965350200700310View
Published, Version of Record (VoR) Open

Abstract

Objective The objective of this study was to determine whether a triple therapy regimen incorporating twice-daily saquinavir is as effective as a three-times daily regimen. Methods This was an open-label, Phase III, multicentre, 48-week study involving 837 HIV-1-infected patients randomised to one of the following: saquinavir soft gel capsule (SGC) 1200 mg three-times daily, plus two nucleoside reverse transcriptase inhibitors (NRTIs) (arm A); saquinavir SGC 1600 mg twice-daily, plus two NRTIs (arm B); saquinavir SGC 1200 mg twice-daily and nelfinavir 1250 mg twice-daily, plus a single NRTI (arm C). The primary outcome measure was the virological response in arm A versus B and in arm A versus C with respect to the percentage of patients whose plasma HIV-1 RNA levels fell below the level of quantification for the Amplicor assay (<400 copies/ml) at weeks 24 and 48. Results At 48 weeks, the percentage of patients with plasma HIV-1 RNA levels <400 copies/ml was 47.1% (arm A), 45.3% (arm B) and 42.7% (arm C) in the intention-to-treat analysis. The treatment difference between arm B–arm A was -1.8% (95% confidence intervals -10.1, 6.5) and for arm C–arm A was -4.5% (95% confidence intervals -12.7, 3.7) in the intention-to-treat analysis. These differences fell within the maximum allowable difference (±12%) for arm B compared with arm A. At week 24, the percentage of patients with HIV-1 RNA levels <400 copies/ml was 59.6% (arm A), 57.6% (arm B) and 51.3% (arm C). Conclusions A twice-daily triple therapy regimen incorporating saquinavir SGC plus two NRTIs was of equivalent efficacy to the three-times daily regimen studied. All regimens were generally well tolerated.

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3 citations in Web of Science
3 citations in Scopus

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Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Infectious Diseases
Pharmacology & Pharmacy
Virology
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