Conditions: Tuberculosis AIDS-related Complex
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 89
Healthy volunteers: no

Brief summary:
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Detailed description:
BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Arms:
arm 1: Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy arm 2: Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide arm 3: Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Interventions: intervention 1: Aerosol Interferon-Gamma intervention 2: Subcutaneous interferon-gamma intervention 3: Placebo
Intervention descriptions: intervention 1: Participants will receive aerosol interferon-gamma. intervention 2: Patients will receive subcutaneous interferon-gamma intervention 3: None

Protocol document: