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

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Abstract
A total of 151 previously untreated patients infected with human immunodeficiency virus type 1 (HIV-1) with CD4 cell counts ⩾200/µL 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 log10 copies/mL) than in groups 2 (1.26 log10 copies/mL) or 3 (1.58 log10 copies/mL; P < .0001). The mean increase in CD4 cell counts was greater in groups 1 (124 cells/µL) and 3(118 cells/µL) than in group 2 (62 cells/µL; 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.

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