> Details

Wheat, L Joseph; Farthing, Charles; Cohen, Calvin; Pierone, Gerald; Lalezari, Jay; Pilson, Robert S; Siemon-Hryczyk, Peggy; Baxter, John; Beer, Victor; Bellos, Nicholas C; Bissett, Jack; Braun, James; Brosgart, Carol; Burman, William; Burnside, Alfred; Cervia, Joe; Cheeseman, Sarah; Cimoch, Paul; Cohen, Calvin; DeJesus, Edwin; Diaz, Leslie; Dieterich, Douglas; Dobkin, Jay; Dretler, Robin; [...]

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

Reference
management

Bookmarks

Remove from
bookmarks

Share this on Whatsapp

Close

Bookmarks



You can manage bookmarks using lists, please log in to your user account for this.
  • Media type: E-Article
  • Title: Efficacy and Safety of Twice-Daily versus Three-Times Daily Saquinavir Soft Gelatin Capsules as Part of Triple Combination Therapy for HIV-1 Infection
  • Contributor: Wheat, L Joseph; Farthing, Charles; Cohen, Calvin; Pierone, Gerald; Lalezari, Jay; Pilson, Robert S; Siemon-Hryczyk, Peggy; Baxter, John; Beer, Victor; Bellos, Nicholas C; Bissett, Jack; Braun, James; Brosgart, Carol; Burman, William; Burnside, Alfred; Cervia, Joe; Cheeseman, Sarah; Cimoch, Paul; Cohen, Calvin; DeJesus, Edwin; Diaz, Leslie; Dieterich, Douglas; Dobkin, Jay; Dretler, Robin; [...]
  • Published: SAGE Publications, 2002
  • Published in: Antiviral Therapy, 7 (2002) 3, Seite 199-209
  • Language: English
  • DOI: 10.1177/135965350200700310
  • ISSN: 1359-6535; 2040-2058
  • Origination:
  • Footnote:
  • Description: 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.
  • Access State: Open Access