Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons.

Author(s): MacArthur RD, Chen L, Peng G, Novak RM, van den Berg-Wolf M, Kozal M, Besch L, Yurik T, Schmetter B, Henley C, Dehlinger M, CPRCA 058 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS

Affiliation(s): Department of Medicine, Division of Infectious Diseases, Wayne State University, Detroit, Michigan 48201, USA. rmacarthur@med.wayne.edu

Publication date & source: 2004-11, HIV Clin Trials., 5(6):361-70.

Publication type: Clinical Trial; Randomized Controlled Trial

PURPOSE: The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial. METHOD: The substudy enrolled 182 patients; mean HIV RNA and CD4+ cell counts at baseline were 5.1 log10 copies/mL and 212 cells/mm3, respectively. RESULTS: After a median follow-up of 28 months, rates of primary endpoint were 57.2 and 67.8 per 100 person-years for the ABC+3TC and ddI+d4T groups (hazard ratio [HR]=0.81, 95% confidence interval [CI] 0.58-1.14, p=.23). CONCLUSION: There was a trend for treatments containing ABC+3TC to be better than treatments containing ddI+d4T with respect to HIV RNA decreases, CD4+ cell count increases, and tolerability.