Status:
COMPLETED
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
Lead Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and...
Detailed Description
This study is a controlled, open, randomized, multi-center clinical trial. The study was authorized by the Clinical Research Ethics Committee of all participating centers and informed written consent ...
Eligibility Criteria
Inclusion
- HIV infection confirmed by ELISA and Western blot
- Age between 18 and 65 years
- Life expectancy greater than two years
- Cutaneous anergy defined by the absence of a reaction (0 mm) to skin reactivity tests with tuberculin, Candida albicans, and parotiditis antigens 72 hours after inoculation.
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 :
332 Patients enrolled
Trial Details
Trial ID
NCT00402610
Start Date
January 1 1994
End Date
December 1 1998
Last Update
October 24 2008
Active Locations (1)
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1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14002