NCT00402454

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Sociedad Andaluza de Enfermedades Infecciosas · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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 Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects.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

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	isoniazid, rifampin + isoniazid or rifampin + pyrazinamide

Timeline

• Start date: 1994-01-01
• Completion: 1998-12-01
• First posted: 2006-11-22
• Last updated: 2007-01-11

Locations

1 site across 1 country: Spain