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A Randomized, Controlled Trial of Indinavir, Zidovudine, and Lamivudine in Adults with Advanced Human Immunodeficiency Virus Type 1 Infection and Prior Antiretroviral Therapy

Hirsch, Martin ; Steigbigel, Roy ; Staszewski, Scholomo ; Mellors, John ; Scerpella, Ernesto ; Hirschel, Bernard ; Lange, Joep ; Squires, Kathleen ; Rawlins, Sandy ; Meibohm, Anne ; Leavitt, Randi

In: The Journal of Infectious Diseases, 1999, vol. 180, no. 3, p. 659-665

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    Titel
    • A Randomized, Controlled Trial of Indinavir, Zidovudine, and Lamivudine in Adults with Advanced Human Immunodeficiency Virus Type 1 Infection and Prior Antiretroviral Therapy
    Autor
    • Hirsch, Martin. Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
    • Steigbigel, Roy. Division of Infectious Diseases, University Hospital at Stony Brook, New York
    • Staszewski, Scholomo. Klinikum der J. W. Goethe University, Frankfurt, Germany
    • Mellors, John. Infectious Diseases Division, University of Pittsburgh Medical Center
    • Scerpella, Ernesto. Department of Medicine, University of Miami, Florida
    • Hirschel, Bernard. Hopital Cantonal Universitaire de Geneva, Switzerland
    • Lange, Joep. Academic Medical Centre, University of Amsterdam, The Netherlands
    • Squires, Kathleen. Division of Infectious Diseases, University of Alabama at Birmingham
    • Rawlins, Sandy. Merck Research Laboratories, West Point, Pennsylvania
    • Meibohm, Anne. Merck Research Laboratories, West Point, Pennsylvania
    • Leavitt, Randi. Merck Research Laboratories, West Point, Pennsylvania
    Dokumententyp
    • Postprint
    Sprache
    • Englisch
    Veröffentlicht in
    • The Journal of Infectious Diseases, 1999, vol. 180, no. 3, p. 659-665. The University of Chicago Press
    Andere elektronische Ausgabe
    Klassifikation
    • Gesundheit
    OAI-PMH-ID
    • oai:doc.rero.ch:296492
    Summary
    A randomized, double-blind, multicenter study of indinavir, zidovudine, and lamivudine was conducted in 320 adults with human immunodeficiency virus type 1 (HIV-1) infection, ⩽50 CD4 cells/mm3, and extensive prior zidovudine therapy. Patients received indinavir, 800 mg every 8 h; zidovudine, 200 mg every 8 h, and lamivudine, 150 mg twice daily; or all 3 drugs for 24 weeks. In an intention-to-treat analysis, proportions of patients with HIV-1 RNA <500 and <50 copies/mL, respectively, at week 24 were 56% and 45% in the indinavir-zido-vudine-lamivudine group, 3% and 2% in the indinavir group, and 0% in the zidovudinelamivudine group. Observed mean CD4 cell increases were 95, 78, and 6 cells/mm3 in the three-, one-, and two-drug arms, respectively. Regimens were generally well tolerated. Patients with advanced HIV-1 infection benefit from triple therapy with indinavir, zidovudine, and lamivudine, although the proportion with optimal response appeared to be lower in patients with low CD4 cell counts