"Azidothymidine (AZT) in Patients with AIDS or Advanced AIDS-Related Complex". The New England Journal of Medicine. 1987. 317(4):185–191. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Does Azidothymidine (AZT) decrease mortality and frequency of opportunistic infections in patients with AIDS or advanced AIDS-related complex (ARC)?
Azidothymidine (AZT) demonstrated a reduction in mortality and opportunistic infections in a selected group of subjects with AIDS or advanced AIDS-related complex, over the 8 to 24 weeks of observation in this study.
The study established the efficacy of AZT in reducing mortality and morbidity among patients with AIDS or advanced AIDS-related complex. AZT was associated with improvements in clinical status, CD4 cell counts, skin-test reactivity, and p24 antigen levels.
The study findings led to the establishment of AZT as a treatment option for patients with AIDS or advanced AIDS-related complex. Subsequent treatment guidelines for HIV/AIDS would consider these findings in their recommendations.
- Double-blind, placebo-controlled trial - N=282 patients with AIDS manifested by Pneumocystis carinii pneumonia or with advanced AIDS-related complex - Intervention: 250 mg of AZT orally every 4 hours - Duration: 24 weeks - Outcomes measured included mortality, opportunistic infections, clinical status, and immunological markers
- Inclusion Criteria: Patients with AIDS and a first episode of P. carinii pneumonia confirmed within the preceding 120 days, or patients with advanced ARC - Exclusion Criteria: Multiple opportunistic infections, neoplasm, hemoglobin <9.5 g/dL, absolute CD4 count >500 cells/mm³, recent antiretroviral therapy, and other specified conditions - Baseline Characteristics: Comparable age, weight, performance status, symptoms, and CD4 cells between AZT and placebo groups
- Participants randomized to receive either AZT or placebo - Criteria for response: Survival, occurrence of opportunistic infections, Karnofsky performance score, stable weight, improved number of CD4 cells
- Primary Outcomes: Mortality and occurrence of opportunistic infections - Secondary Outcomes: Karnofsky performance status, weight changes, CD4 cell counts, skin-test reactivity, serum p24 antigen levels
- Early termination limited long-term safety and efficacy conclusions. - The study did not assess the effectiveness of AZT beyond 24 weeks and larger patient subsets to confirm generalizability. - There were concerns regarding the cumulative toxicity of AZT and durability of immunological benefits.
- The study was funded by the Burroughs Wellcome Co., the manufacturer of AZT.
- Additional studies and trials have since been conducted to assess the long-term benefits and optimal dosing of AZT, which have further informed treatment guidelines and regimens for HIV/AIDS. - Consideration of AZT's role in combination antiretroviral therapy (cART) and the subsequent evolution of HIV treatment strategies.