Randomized double-blind study of combination therapy with didanosine and stavudine in HIV-infected individuals

The combination of two nucleoside analogues, didanosine (2',3'- dideoxyinosine or ddI) and stavudine (2',3'-didehydro-2',3'-dideoxythymidine or d4T) was studied in a double-blind dose-ranging trial to provide information about toxicity and efficacy. The 86 patients studied were antiretroviral naive and had pretreatment CD4 cell counts between 200 and 500 cells/mm³. The combination was well tolerated, with no evidence of dose- related side effects and mini- real development of peripheral neuropathy. There was a sustained decrease in human immunodeficiency virus (HIV) viral RNA levels, which appeared greater in patients receiving a full dose of one or both compounds. A concomitant increase in CD4 cell numbers, which was sustained over 52 weeks of follow-up and which was also dose related, was observed. This combination therapy deserves further study, particularly as part of triple-drug regimens.