Open-Label Phase II Trial of Amprenavir, Abacavir, and Fixed-Dose Zidovudine/Lamivudine in Newly and Chronically HIV-1–Infected Patients
作者:
Rhonda,
Kost Arlene,
Hurley Linqi,
Zhang Mika,
Vesanen Andrew,
Talal Scott,
Furlan Paul,
Caldwell Judy,
Johnson Lynn,
Smiley David,
Ho Martin,
期刊:
JAIDS Journal of Acquired Immune Deficiency Syndromes
(OVID Available online 2001)
卷期:
Volume 26,
issue 4
页码: 332-339
ISSN:1525-4135
年代: 2001
出版商: OVID
关键词: Amprenavir;Abacavir;Zidovudine;Lamivudine;HIV-1 infection
数据来源: OVID
摘要:
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/&mgr;l (newly infected,p< .001), and+155 cells/&mgr;l (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.
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