The ALBI trial:: A randomized controlled trial comparing stavudine plus didanosine with zidovudine plus lamivudine and a regimen alternating both combinations in previously untreated patients infected with human immunodeficiency virus

A total of 151 previously untreated patients infected with human immunodeficiency virus type 1 (HIV-1) with CD4 cell counts greater than or equal to 200/mu L and plasma HIV-1 RNA levels of 10,000-100,000 copies/mL were randomly assigned to 24 weeks of open-labeled stavudine plus didanosine (group 1), zidovudine plus lamivudine (group 2), or stavudine plus didanosine followed by zidovudine plus lamivudine (group 3), The mean decrease in HIV-1 RNA level was greater in group 1 (2.26 log(10) copies/mL) than in groups 2 (1.26 log(10) copies/mL) or 3 (1.58 log(10) copies/mL; P < .0001). The mean increase in CD4 cell counts was greater in groups 1 (124 cells/mu L) and 3 (118 cells/mu L) than in group 2 (62 cells/mu L; P = .02). All regimens were generally well tolerated. The combination of stavudine plus didanosine reduced plasma HIV-1 RNA concentrations and increased CD4 cell counts more effectively than did the combination of zidovudine plus lamivudine or the regimen alternating both combinations.