Open-Label Phase II Trial of Amprenavir, Abacavir, and Fixed-Dose Zidovudine/Lamivudine in Newly and Chronically HIV-1-Infected Patients [Kost RG, et al. JAIDS 2001;26:332]: This is a Phase II clinical trial of 41 treatment-naïve patients who were newly infected patients (27) or chronically infected patients (14) treated with amprenavir (1200 mg bid), abacavir (300 mg bid), and Combivir (1 bid). At week 48 all patients had achieved a viral load of <500 copies/mL, and 80% had <50 c/mL by as-treated analysis. The intent-to-treat analysis showed 80% achieved a VL of <500 c/mL. The mean CD4 cell increase was 150/mm³. The major problem encountered was intolerance, especially GI, which mandated single-drug substitutions in 19%. There were six patients who had CSF studies that showed a decrease in CSF levels of HIV that corresponded to the decreases in serum levels.
Comment: The results were impressive with 80% achieving <500 c/mL by intent-to-treat analysis, but there was a major problem with tolerance of the regimen. It was noted in the discussion that this is likely to be improved with "new formulations of amprenavir that are currently under development."
posted 5/16/2001

back to news table of contents