Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

Sociedad Andaluza de Enfermedades Infecciosas

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: isoniazid, rifampin + isoniazid or rifampin + pyrazinamide

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00402454

FIS 94/0071B

GAEI 94/0071B

Details and patient eligibility

About

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.

Full description

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 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects.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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV infection confirmed by ELISA and Western blot
Age between 18 and 65 years
Life expectancy greater than two years
Reactivity to PPD > 5 mm

Exclusion criteria

Presence of active tuberculosis
Background of previous antituberculosis therapy or chemoprophylaxis
Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
Pregnancy
Undergoing treatment incompatible with any of the drugs used in the study.