drugset / Trial / NCT00402610

A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy

NCT00402610 ↗

Phase 4 Completed 332 enrolled Sociedad Andaluza de Enfermedades Infecciosas
RandomizedParallel-groupOpen-labelPrevention

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 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.

Timeline

Start
1994-01
Primary completion
—
Completion
1998-12

Outcome

Missed primary endpoint

paper The results showed no significant decrease in the risk of developing tuberculosis with any of the evaluated regimens PMID 12809582 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoniazid Small molecule — —
Subject Pyrazinamide Small molecule — —
Subject Rifampicin Small molecule — —