AZT Trial
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
95.0% male
N = 282
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
1
19
19.0 patient
14.3 patient
9.5 patient
4.8 patient
0.0 patient
Azidothymidine
Placebo
Significant decrease ▼
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.
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