Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis; AIDS-related Complex
Intervention: Aerosol Interferon-Gamma (Drug); Subcutaneous interferon-gamma (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s): William Rom, MD, MPH, Principal Investigator, Affiliation: NYU School of Medicine
Summary
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb)
infection and will modulate that response with interferon-gamma.
Clinical Details
Official title: Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Sputum Conversion
Secondary outcome: Chest CT ScanBronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
The Lung Institute at University of Cape Town, Cape Town, South Africa
NYU School of Medicine, New York, New York 10016, United States
Additional Information
Starting date: April 2005
Last updated: June 9, 2014
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