Abstract
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.
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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AIDS Dementia Complex / drug therapy
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AIDS Dementia Complex / immunology
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AIDS Dementia Complex / virology
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Acquired Immunodeficiency Syndrome / drug therapy
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Acquired Immunodeficiency Syndrome / immunology
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Acquired Immunodeficiency Syndrome / virology
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Adult
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Anti-HIV Agents / administration & dosage
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Anti-HIV Agents / adverse effects
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Anti-HIV Agents / pharmacology
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Anti-HIV Agents / therapeutic use*
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CD4 Lymphocyte Count
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Carbamates
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Chronic Disease
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Dideoxynucleosides / adverse effects
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Dideoxynucleosides / pharmacology
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Dideoxynucleosides / therapeutic use*
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Digestive System / drug effects
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Digestive System / immunology
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Digestive System / virology
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Drug Synergism
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Ethnicity
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Female
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Furans
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HIV Infections / drug therapy*
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HIV Infections / immunology
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HIV Infections / virology
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HIV-1 / drug effects
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HIV-1 / genetics
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HIV-1 / immunology
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HIV-1 / physiology
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Humans
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Lamivudine / administration & dosage
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Lamivudine / adverse effects
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Lamivudine / pharmacology
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Lamivudine / therapeutic use*
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Lymphocyte Subsets / drug effects
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Lymphocyte Subsets / immunology
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Male
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Pregnancy
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RNA, Viral / analysis
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Research Design
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Sulfonamides / adverse effects
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Sulfonamides / pharmacology
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Sulfonamides / therapeutic use*
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Treatment Refusal
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Zidovudine / administration & dosage
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Zidovudine / adverse effects
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Zidovudine / pharmacology
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Zidovudine / therapeutic use*
Substances
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Anti-HIV Agents
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Carbamates
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Dideoxynucleosides
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Furans
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RNA, Viral
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Sulfonamides
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Lamivudine
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Zidovudine
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amprenavir
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abacavir