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

• Status: Completed
• Trial end date: 1998-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sociedad Andaluza de Enfermedades Infecciosas
• Treatments: Isoniazid; Pyrazinamide; Rifampin

Criteria

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.