Role of co-trimoxazole prophylaxis in reducing mortality in HIV infected adults being treated for tuberculosis: randomised clinical trial.
BMJ
; 337: a257, 2008 Jul 10.
Article
em En
| MEDLINE
| ID: mdl-18617486
ABSTRACT
OBJECTIVE:
To assess the impact of prophylactic oral co-trimoxazole in reducing mortality in HIV positive Zambian adults being treated for pulmonary tuberculosis.DESIGN:
Double blind placebo controlled randomised clinical trial.PARTICIPANTS:
Two groups of antiretroviral treatment naive adults with HIV infection patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; previously treated patients not receiving treatment. INTERVENTION Oral co-trimoxazole or matching placebo daily. Primary outcome measures Time to death and occurrence of serious adverse events related to study drug.RESULTS:
1003 patients were randomised 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1012.6 person years of follow-up. A total of 310 (147 co-trimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis, the hazard ratio for death (co-trimoxazoleplacebo) was 0.79 (95% confidence interval 0.63 to 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with study drug, the hazard ratio was 0.65 (0.45 to 0.93).CONCLUSIONS:
Prophylaxis with co-trimoxazole reduces mortality in HIV infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated. TRIAL REGISTRATION Current Controlled Trials ISRCTN15281875.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Tuberculose Pulmonar
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Infecções por HIV
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Combinação Trimetoprima e Sulfametoxazol
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Anti-Infecciosos
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
BMJ
Assunto da revista:
MEDICINA
Ano de publicação:
2008
Tipo de documento:
Article