3-Year Suppression of HIV Viremia with Indinavir, Zidovudine, and Lamivudine [Gulick RM, et al. Ann Intern Med 2000; 133: 35]: This is the three-year follow-up report of the Merck Sharp Dohm study 035. The initial protocol was a three-arm study, but the present report deals exclusively with the 33 patients assigned to receive the triple-drug regimen. Enrollment criteria were a viral load >20,000 copies/mL, and a CD4 count of 50 - 400 cells/mm³ in patients who were treatment-naïve except for prior AZT exposure. At three years, 21 of 31 patients had a viral load of <500 copies/mL (68%), and 20 of 31 had levels <50 copies/mL (65%). The median increase in CD4 cell count was 230 cells/mm³. Nephrolithiasis was noted in 12 of the 33 patients (36%).
Comment: This is the longest ongoing study of triple-therapy and is the one commonly cited for showing that the benefit of HAART can be sustained over a period of years. posted 7/19/2000