Didanosine in HIV-1–Infected Patients Experiencing Failure of Antiretroviral Therapy: A Randomized Placebo-Controlled Trial

BackgroundThe antiviral efficacy of didanosine in patients experiencing virological failure is not well known MethodsA total of 168 patients (139 men and 29 women) receiving stable antiretroviral therapy with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 1000–100,000 copies/mL were randomly assigned to have didanosine (n=111) or placebo (n=57) added to their currently failing regimen for 4 weeks. The primary efficacy end point was the change in HIV-1 RNA level from baseline to week 4 ResultsAt baseline, the median HIV-1 RNA level was 3.8 log10 copies/mL, the median CD4 cell count was 378 cells/mm3, and the median number of nucleoside reverse-transcriptase inhibitor–associated mutations (NAMs) was 4. At week 4, a significant decrease in the median HIV-1 RNA level was observed in the didanosine group, compared with that in the placebo group (−0.56 vs. +0.07 log10 copies/mL, respectively) (P