Status:
COMPLETED
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Tuberculosis
AIDS-related Complex
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 pe...
Eligibility Criteria
Inclusion
- Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
- Cluster of Differentiation 4 greater than 200 if HIV positive
- Ability to sign consent
- Bilateral, cavitary pulmonary TB
Exclusion
- Multidrug-resistant (MDR) TB
- Extrapulmonary TB
- HIV positive with opportunistic infection within 30 days of study entry
- Cancer
- Asthma
- Pregnant or lactating women
- Chronic heart disease
- Chronic liver disease
- Chronic renal disease
- Seizure disorder
- Bleeding or clotting disorder
- Diabetes mellitus
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00201123
Start Date
April 1 2005
End Date
August 1 2007
Last Update
December 16 2016
Active Locations (2)
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1
NYU School of Medicine
New York, New York, United States, 10016
2
The Lung Institute at University of Cape Town
Cape Town, South Africa