Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV … (NCT00402454) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Spain300 participantsStarted 1994-01
Plain-language summary
To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Development of Tuberculosis
2
Suspension of chemoprophylaxis due to adverse effects
Trial details
NCT IDNCT00402454
SponsorSociedad Andaluza de Enfermedades Infecciosas