HIV Infections Clinical Trial
Official title:
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.
DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316
HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to
isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105
to pyrazinamide and rifampin for two months (2RZ).
RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in
6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was
1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned
chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were
withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences
were found among the three regimens.
CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor
observed a higher incidence of hepatotoxicity in patients who received 2RZ.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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