Open-label phase II trial of amprenavir, abacavir, and fixed-dose zidovudine/lamivudine in newly and chronically HIV-1--infected patients

J Acquir Immune Defic Syndr. 2001 Apr 1;26(4):332-9. doi: 10.1097/00126334-200104010-00007.

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

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS Dementia Complex / drug therapy
  • AIDS Dementia Complex / immunology
  • AIDS Dementia Complex / virology
  • Acquired Immunodeficiency Syndrome / drug therapy
  • Acquired Immunodeficiency Syndrome / immunology
  • Acquired Immunodeficiency Syndrome / virology
  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / pharmacology
  • Anti-HIV Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Carbamates
  • Chronic Disease
  • Dideoxynucleosides / adverse effects
  • Dideoxynucleosides / pharmacology
  • Dideoxynucleosides / therapeutic use*
  • Digestive System / drug effects
  • Digestive System / immunology
  • Digestive System / virology
  • Drug Synergism
  • Ethnicity
  • Female
  • Furans
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / genetics
  • HIV-1 / immunology
  • HIV-1 / physiology
  • Humans
  • Lamivudine / administration & dosage
  • Lamivudine / adverse effects
  • Lamivudine / pharmacology
  • Lamivudine / therapeutic use*
  • Lymphocyte Subsets / drug effects
  • Lymphocyte Subsets / immunology
  • Male
  • Pregnancy
  • RNA, Viral / analysis
  • Research Design
  • Sulfonamides / adverse effects
  • Sulfonamides / pharmacology
  • Sulfonamides / therapeutic use*
  • Treatment Refusal
  • Zidovudine / administration & dosage
  • Zidovudine / adverse effects
  • Zidovudine / pharmacology
  • Zidovudine / therapeutic use*

Substances

  • Anti-HIV Agents
  • Carbamates
  • Dideoxynucleosides
  • Furans
  • RNA, Viral
  • Sulfonamides
  • Lamivudine
  • Zidovudine
  • amprenavir
  • abacavir