6/28/23, 12:51 AM AZT Trial Pathway Feedback Search Clinical Topics Home Studies AZT Trial AZT Trial Disease Human immunodeficiency virus i Trial question What is the role of azidothymidine in patients with AIDS and AIDS-related complex? Study design Multi-center Double blinded RCT Population Characteristics of study participants 5.0% female N = 282 95.0% male 282 patients (13 female, 269 male) Inclusion criteria: patients with AIDS and AIDS-related complex Key exclusion criteria: multiple episodes of P. carinii pneumonia or any other opportunistic infection or neoplasm Interventions N=145 azidothymidine (250 mg PO every 4 hours for a total of 24 weeks) N=137 placebo (matching placebo PO every 4 hours for a total of 24 weeks) Primary outcome Death during study period 19.0 patient 19 https://web.pathway.md/studies/recVF3OoXo6P4eMnZ 1/2 6/28/23, 12:51 AM AZT Trial Pathway p 9 14.3 patient 9.5 patient 4.8 patient Significant decrease 1 0.0 patient Azidothymidine Placebo Significant decrease in death during the study period (1 patient vs. 19 patient; RR 0.05, 95% CI 0.02 to 0.08) Secondary outcomes Significant decrease in frequency of opportunistic infections (24 vs. 45; RR 0.53, 95% CI 0.22 to 0.84) Significant increase in CD4 cell count (0.96 vs. 0.7; RR 1.37, 95% CI 0.56 to 2.18) Significant increase in skin-test anergy reversal (29% vs. 9%; RR 3.22, 95% CI 1.31 to 5.13) Safety outcomes Significant differences in reversal of skin test anergy (29% vs. 9%, p < 0.001) and increase in the number of CD4 cells in AZT recipients than in placebo (p < 0.001). Conclusion In patients with AIDS and AIDS-related complex, azidothymidine was superior to placebo with respect to death during the study period. Reference Fischl MA, Richman DD, Grieco MH et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. A double-blind, placebo-controlled trial. N Engl J Med. 1987 Jul 23;317(4):185-91. Open reference URL https://web.pathway.md/studies/recVF3OoXo6P4eMnZ 2/2