Status:
COMPLETED
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Lead Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1994
Trial Type :
INTERVENTIONAL
End Date :
December 1 1998
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00402454
Start Date
January 1 1994
End Date
December 1 1998
Last Update
January 11 2007
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14002