NCT00201123

Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs

Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis
• AIDS-related Complex

Interventions

Type	Name	Description
DRUG	Aerosol Interferon-Gamma	Participants will receive aerosol interferon-gamma.
DRUG	Subcutaneous interferon-gamma	Patients will receive subcutaneous interferon-gamma
OTHER	Placebo

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-01-01
• Completion: 2007-08-01
• First posted: 2005-09-20
• Last updated: 2016-12-16
• Results posted: 2014-06-10

Locations

2 sites across 2 countries: United States, South Africa