A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naive HIV-1-infected Thai patients

Objective: To assess the efficacy and tolerability of a triple nucleoside r everse transcriptase inhibitor combination of zidovudine, lamivudine, and d idanosine therapy, Design: A randomized open-label trial. Patients: Antiretroviral-naive HIV-infected patients with CD4(+) cell count s of 100 to 500 cells/mul. Methods: A total of 106 patients were randomly assigned to 300 mg of zidovu dine (200 mg for body weight < 60 kg) twice daily plus 150 mg of lamivudine twice daily plus 200 mg of didanosine (125 mg for body weight < 60 kg) twi ce daily (n = 53) or to zidovudine plus lamivudine (n = 53) for 48 weeks. Main Outcome Measures: Degree and duration of reduction of HIV-1 RNA load a nd increase in CD4(+) cell counts from baseline and development of drug-rel ated toxicities. Results: At 48 weeks, triple drug therapy showed greater declines in plasma HIV-RNA levels from the beginning of treatment than double drug therapy (1 .86 vs, 1.15 log(10) copies/ml, respectively; p < .001). The proportions of patients with HIV-RNA < 50 copies/ml in an intention-to-treat analysis wer e 54.7% (29 of 53 patients) and 11.3% (6 of 53 patients) in the triple and double drug therapy, respectively (p = .001). There was no significant diff erence in increase of CD4 count. Conclusion: Triple drug therapy with zidovudine, lamivudine, and didanosine was significantly more effective in inducing sustained immunologic and vir ologic responses than the double combination of zidovudine and lamivudine.