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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.

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 infecti...

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Published in:Lancet Vol. 353; no. 9163; pp. 1469 - 1476
Main Authors: Wiktor SZ, Sassan-Morokro M, Grant AD, Abouya L, Karon JM, Maurice C, Djomand G, Ackah A, Domoua K, Kadio A, Yapi A, Combe P, Tossou O, Roels TH, Lackritz EM, Coulibaly D, De Cock JM, Coulibaly I, Greenberg AE, Wiktor, S Z
Format: research tables/charts randomized controlled trial Journal Article
Published: Lancet 5/1/1999
Online Access:View this record in EBSCOhost
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      dt: 5/1/1999
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      pub: Lancet
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        atl: 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.
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        au:
          Wiktor SZ
          Sassan-Morokro M
          Grant AD
          Abouya L
          Karon JM
          Maurice C
          Djomand G
          Ackah A
          Domoua K
          Kadio A
          Yapi A
          Combe P
          Tossou O
          Roels TH
          Lackritz EM
          Coulibaly D
          De Cock JM
          Coulibaly I
          Greenberg AE
          Wiktor, S Z
        affil: Projet RETRO-CI, Abidjan, Côte d'Ivoire
      sug:
        subj:
          Trimethoprim-Sulfamethoxazole Combination Therapeutic Use
          HIV Infections Complications
          Tuberculosis, Pulmonary Complications
          Tuberculosis, Pulmonary Drug Therapy
          AIDS-Related Opportunistic Infections Prevention and Control
          Cote d'Ivoire
          Random Assignment
          Clinical Trials
          Survival Analysis
          Confidence Intervals
          P-Value
          HIV-1
          HIV Infections Mortality
          Hospitalization
          Funding Source
          Medication Compliance
          CD4 Lymphocyte Count
          Adolescence
          Adult
          Middle Age
          Male
          Female
          Human
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
          Female
      ab: 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.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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