Changing Clinical Presentation and Survival in HIV-Associated Tuberculosis After Highly Active Antiretroviral Therapy

Abstract

Summary: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/μl (newly infected, p < .001), and +155 cells/μl (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. Address correspondence and reprint requests to Rhonda G. Kost, Aaron Diamond AIDS Research Center, 455 First Ave., New York, NY 10016 U.S.A.; e-mail:[email protected] J. Johnson, L. Smiley, and P. Caldwell are employees of Glaxo-Wellcome, Inc. Presented in part at the 6th Conference on Retroviruses and Opportunistic Infections, Chicago, Illinois, 1999. Manuscript received June 21, 2000; accepted November 1, 2000. © 2001 Lippincott Williams & Wilkins, Inc.