title: Randomised, placebo-controlled trial to evaluate co-trimoxazole to reduce mortality and morbidity in HIV-infected post-natal women in Zambia (TOPAZ).
abstract: OBJECTIVE
  To evaluate the role of prophylactic trimethoprim-sulfamethoxazole (co-trimoxazole) antibacterial prophylaxis in reducing morbidity and mortality in HIV-infected post-natal women in southern Africa.
  
  
  METHODS
  Double-blind placebo-controlled trial. HIV-infected women with WHO stage 2 or 3 HIV disease who had recently delivered in the Department of Obstetrics and Gynaecology at the University Teaching Hospital, Lusaka, Zambia were randomised to receive daily co-trimoxazole (cotox) or matched placebo daily for the duration of the trial. Participants were followed up for a minimum of 1 year. Primary outcome measures were mortality from any cause or hospital admission and serious adverse events.
  
  
  RESULTS
  Of 600 women randomised, follow-up information was available from 355 (180 cotox, 175 placebo) participants. Thirty-six (17 cotox, 19 placebo) women died during the trial, and another 11 (5 cotox, 6 placebo) were admitted to hospital. There was no significant difference in the combined event rates between the two treatment arms: HR = 0.82, 95% CI (0.46, 1.45), P = 0.49; morbidity was reduced over a range of symptoms. Secondary analyses of the outcome in babies indicated some evidence of reduced mortality in those whose mothers were allocated cotox.
  
  
  CONCLUSIONS
  Follow-up rates were poor; there was no evidence that co-trimoxazole prophylaxis reduced mortality or hospital admission rates, although fewer symptoms were reported in the cotox arm. Cotox was safe and well tolerated.
authors.affiliation: Medical Research Council Clinical Trials Unit, London, UK. ajn@ctu.mrc.ac.uk
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Nunn
authors.forename: Peter B
authors.initials: PB
authors.lastname: Mwaba
authors.forename: Chifumbe
authors.initials: C
authors.lastname: Chintu
authors.forename: Angela M
authors.initials: AM
authors.lastname: Crook
authors.forename: Janet H
authors.initials: JH
authors.lastname: Darbyshire
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.forename: Alimuddin I
authors.initials: AI
authors.lastname: Zumla
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000401:mortality / Q000517:prevention & control*; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis / Q000009:adverse effects / Q000379:methods*; D001424:Bacterial Infections / Q000401:mortality / Q000517:prevention & control*; D004812:Epidemiologic Methods; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D055118:Medication Adherence; D011181:Postnatal Care / Q000379:methods; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D015662:Trimethoprim, Sulfamethoxazole Drug Combination