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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 Scan

Bronchoalveolar 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

Page last updated: August 23, 2015

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