Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
|Tuberculosis AIDS-related Complex||Drug: Aerosol Interferon-Gamma Drug: Subcutaneous interferon-gamma Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome|
- Sputum Conversion [ Time Frame: Measured at 16 Weeks ]
- Chest Cavity Size [ Time Frame: 16 Weeks ]
- Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: 16 Weeks ]
|Study Start Date:||April 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: Standard Treatment
Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
Experimental: Aerosol Interferon-gamma
Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Drug: Aerosol Interferon-Gamma
Participants will receive aerosol interferon-gamma.
Experimental: Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Drug: Subcutaneous interferon-gamma
Patients will receive subcutaneous interferon-gamma
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201123
|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|
|Principal Investigator:||William Rom, MD, MPH||NYU School of Medicine|