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

A Phase II clinical trial was designed to evaluate the efficacy and tolerab ility 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 leve ls 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 me an change in CD4 was (+)150 cells/mul (newly infected, p < .001), and (+)15 5 cells/mul (chronically infected, p < .001). At Week 48, evidence of cellu lar activation persisted in both cohorts. A twice-daily regimen of amprenav ir, abacavir, and ZDV/3TC affords potent Viral suppression and significant increases in total CD4(+) cells in HIV-1-infected study subjects. Patient i ntolerance may limit the efficacy of this combination.