title: Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidity and mortality in HIV-1-infected patients with tuberculosis in Abidjan, Côte d'Ivoire: a randomised controlled trial.
abstract: BACKGROUND
  There is a high incidence of opportunistic infection among HIV-1-infected patients with tuberculosis in Africa and, consequently, high mortality. We assessed the safety and efficacy of trimethoprim-sulphamethoxazole 800 mg/160 mg (co-trimoxazole) prophylaxis in prevention of such infections and in decrease of morbidity and mortality.
  
  
  METHODS
  Between October, 1995, and April, 1998, we enrolled 771 HIV-1 seropositive and HIV-1 and HIV-2 dually seroreactive patients who had sputum-smear-positive pulmonary tuberculosis (median age 32 years [range 18-64], median CD4-cell count 317 cells/microL) attending Abidjan's four largest outpatient tuberculosis treatment centres. Patients were randomly assigned one daily tablet of co-trimoxazole (n=386) or placebo (n=385) 1 month after the start of a standard 6-month tuberculosis regimen. We assessed adherence to study drug and tolerance monthly for 5 months and every 3 months thereafter, as well as rates of admission to hospital.
  
  
  RESULTS
  Rates of laboratory and clinical adverse events were similar in the two groups. 51 patients in the co-trimoxazole group (13.8/100 person-years) and 86 in the placebo group (25.4/100 person-years) died (decrease In risk 46% [95% CI 23-62], p<0.001). 29 patients on co-trimoxazole (8.2/100 person-years) and 47 on placebo (15.0/100 person-years) were admitted to hospital at least once after randomisation (decrease 43% [10-64]), p=0.02). There were significantly fewer admissions for septicaemia and enteritis in the co-trimoxazole group than in the placebo group.
  
  
  CONCLUSIONS
  In HIV-1-infected patients with tuberculosis, daily co-trimoxazole prophylaxis was well tolerated and significantly decreased mortality and hospital admission rates. Our findings may have important implications for improvement of clinical care for such patients in Africa.
authors.affiliation: Projet RETRO-CI, Abidjan, Côte d'Ivoire. szw0@cdc.gov
authors.forename: S Z
authors.initials: SZ
authors.lastname: Wiktor
authors.forename: M
authors.initials: M
authors.lastname: Sassan-Morokro
authors.forename: A D
authors.initials: AD
authors.lastname: Grant
authors.forename: L
authors.initials: L
authors.lastname: Abouya
authors.forename: J M
authors.initials: JM
authors.lastname: Karon
authors.forename: C
authors.initials: C
authors.lastname: Maurice
authors.forename: G
authors.initials: G
authors.lastname: Djomand
authors.forename: A
authors.initials: A
authors.lastname: Ackah
authors.forename: K
authors.initials: K
authors.lastname: Domoua
authors.forename: A
authors.initials: A
authors.lastname: Kadio
authors.forename: A
authors.initials: A
authors.lastname: Yapi
authors.forename: P
authors.initials: P
authors.lastname: Combe
authors.forename: O
authors.initials: O
authors.lastname: Tossou
authors.forename: T H
authors.initials: TH
authors.lastname: Roels
authors.forename: E M
authors.initials: EM
authors.lastname: Lackritz
authors.forename: D
authors.initials: D
authors.lastname: Coulibaly
authors.forename: K M
authors.initials: KM
authors.lastname: De Cock
authors.forename: I M
authors.initials: IM
authors.lastname: Coulibaly
authors.forename: A E
authors.initials: AE
authors.lastname: Greenberg
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D007560:Cote d'Ivoire / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy / Q000401:mortality; D015497:HIV-1; D015498:HIV-2; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*; D014376:Tuberculosis / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality
chemical_list: D000890:Anti-Infective Agents; D015662:Trimethoprim, Sulfamethoxazole Drug Combination