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 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/muL) attending Abidjan's four largest outpatient tuberculosis treatment centres.
Patients were randomly assigned one daily tablet of co-trimox azole (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 cotrimoxazole group (13.8/100 person-years) and 86 in the placebo group (25.4/100 person-years) died (decrease In risk 46% [95% Cl 23-62], p<0.001). 29 patients on cotrimoxazole (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). (...)
Mots-clés Pascal : SIDA, Virose, Infection, Virus HIV1, Virus immunodéficience humaine, Lentivirus, Retroviridae, Virus, Association, Tuberculose, Mycobactériose, Bactériose, Essai thérapeutique contrôlé, Randomisation, Triméthoprime, Sulfaméthoxazole, Chimioprophylaxie, Morbidité, Mortalité, Efficacité traitement, Côte d'Ivoire, Afrique, Homme, Etude longitudinale, Evaluation, Immunopathologie, Immunodéficit, Antiinfectieux, Prévention
Mots-clés Pascal anglais : AIDS, Viral disease, Infection, HIV-1 virus, Human immunodeficiency virus, Lentivirus, Retroviridae, Virus, Association, Tuberculosis, Mycobacterial infection, Bacteriosis, Controlled therapeutic trial, Randomization, Trimethoprim, Sulfamethoxazole, Chemoprophylaxis, Morbidity, Mortality, Treatment efficiency, Ivory Coast, Africa, Human, Follow up study, Evaluation, Immunopathology, Immune deficiency, Antiinfectious, Prevention
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0271339
Code Inist : 002B05C02D. Création : 16/11/1999.