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

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sociedad Andaluza de Enfermedades Infecciosas
• Treatments: Isoniazid; Pyrazinamide; Rifampin

Criteria

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.