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

This study has been completed.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT00201123

First received: September 16, 2005

Last updated: December 2, 2015

Last verified: December 2015

History of Changes

Purpose

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Condition	Intervention	Phase
Tuberculosis AIDS-related Complex	Drug: Aerosol Interferon-Gamma Drug: Subcutaneous interferon-gamma Other: Placebo	Phase 2


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Interferon Interferon Gamma-1b

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Sputum Conversion [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chest CT Scan [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]


Enrollment:	96
Study Start Date:	April 2005
Study Completion Date:	August 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Standard Treatment Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy	Other: Placebo
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

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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201123

Locations


United States, New York
NYU School of Medicine
New York, New York, United States, 10016
South Africa
The Lung Institute at University of Cape Town
Cape Town, South Africa

Sponsors and Collaborators

New York University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	William Rom, MD, MPH	NYU School of Medicine

More Information

Publications:

Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.


Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00201123 History of Changes
Other Study ID Numbers:	264 R01HL059832-06
Study First Received:	September 16, 2005
Results First Received:	January 22, 2014
Last Updated:	December 2, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Tuberculosis AIDS-Related Complex Acquired Immunodeficiency Syndrome HIV Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Interferons Interferon-gamma Antineoplastic Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016

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