HIV Infections Clinical Trial
Official title:
A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy
Verified date | November 2006 |
Source | Sociedad Andaluza de Enfermedades Infecciosas |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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 open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.
Status | Completed |
Enrollment | 332 |
Est. completion date | December 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Reina Sofía | Córdoba |
Lead Sponsor | Collaborator |
---|---|
Sociedad Andaluza de Enfermedades Infecciosas |
Spain,
Rivero A, López-Cortés L, Castillo R, Lozano F, García MA, Díez F, Escribano JC, Canueto J, Pasquau J, Hernández JJ, Polo R, Martínez-Marcos FJ, Kindelán JM, Rey R; Grupo Andaluz para el estudio de las Enfermedades Infecciosas (GAEI). [Randomized trial of — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of tuberculosis | |||
Secondary | Suspension of chemoprophylaxis due to adverse effects | |||
Secondary | Mortality |
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