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

Lancet. 1999 May 1;353(9163):1469-75. doi: 10.1016/s0140-6736(99)03465-0.


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.

Findings: 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.

Interpretation: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy
  • AIDS-Related Opportunistic Infections / epidemiology
  • AIDS-Related Opportunistic Infections / prevention & control*
  • Adolescent
  • Adult
  • Anti-Infective Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Cote d'Ivoire / epidemiology
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy
  • HIV Infections / mortality
  • HIV-1*
  • HIV-2
  • Hospitalization / statistics & numerical data
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Survival Analysis
  • Trimethoprim, Sulfamethoxazole Drug Combination / therapeutic use*
  • Tuberculosis / drug therapy*
  • Tuberculosis / epidemiology
  • Tuberculosis / mortality


  • Anti-Infective Agents
  • Trimethoprim, Sulfamethoxazole Drug Combination