Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Recruitment status was Active, not recruiting
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Drug: IRPE Anti-Tuberculous Therapy
Drug: Aerosol Interferon-Gamma
Drug: Subcutaneous Interferon-Gamma
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Host Response to TB and AIDS|
- Sputum conversion (measured at Weeks 4 and 8)
- Chest CT scan
- BAL to measure flow of cytometry and cytokine levels (measured at Month 4)
|Study Start Date:||April 2005|
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.
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.
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|The Lung Institute at University of Cape Town|
|Cape Town, South Africa|