Open AccessOpen-Label Phase II Trial of Amprenavir, Abacavir, and Fixed-Dose Zidovudine/Lamivudine in Newly and Chronically HIV-1–Infected Patients
Author(s) -
Rhonda G. Kost,
Arlene Hurley,
Linqi Zhang,
Mika Vesanen,
Andrew H. Talal,
Scott N. Furlan,
Paul T. Caldwell,
Justin M. Johnson,
Lynn Smiley,
David D. Ho,
Martin Markowitz
Publication year - 2001
Publication title -
journal of acquired immune deficiency syndromes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.162
H-Index - 157
eISSN - 1944-7884
pISSN - 1525-4135
DOI - 10.1097/00126334-200104010-00007
Subject(s) - amprenavir , abacavir , zidovudine , lamivudine , medicine , regimen , viral load , tolerability , virology , gastroenterology , pharmacology , immunology , viral disease , biology , human immunodeficiency virus (hiv) , protease , virus , adverse effect , hiv 1 protease , hepatitis b virus , biochemistry , enzyme
A Phase II clinical trial was designed to evaluate the efficacy and tolerability of twice-daily abacavir, amprenavir, and zidovudine (ZDV)/lamivudine (3TC) in HIV-1-infected study subjects naive to protease inhibitors and 3TC. Plasma and cerebrospinal fluid (CSF) HIV-1 RNA levels and T-cell subsets were measured. In all, 27 newly diagnosed and 12 chronically HIV-1-infected study subjects are included in the analysis. Week 48 plasma HIV-1 RNA levels were <500 copies/ml in 100% of study subjects, and <50 copies/ml in 80% of chronically infected and 100% of newly infected study subjects. The mean change in CD4 was (+)150 cells/microl (newly infected, p <.001), and (+)155 cells/microl (chronically infected, p <.001). At Week 48, evidence of cellular activation persisted in both cohorts. A twice-daily regimen of amprenavir, abacavir, and ZDV/3TC affords potent viral suppression and significant increases in total CD4(+) cells in HIV-1--infected study subjects. Patient intolerance may limit the efficacy of this combination.