Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
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ClinicalTrials.gov Identifier: NCT00201123 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Results First Posted
: June 10, 2014
Last Update Posted
: December 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis AIDS-related Complex | Drug: Aerosol Interferon-Gamma Drug: Subcutaneous interferon-gamma Other: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Standard Treatment
Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
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Other: Placebo |
Experimental: Aerosol Interferon-gamma
Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
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Drug: Aerosol Interferon-Gamma
Participants will receive aerosol interferon-gamma.
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Experimental: Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
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Drug: Subcutaneous interferon-gamma
Patients will receive subcutaneous interferon-gamma
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- Sputum Conversion [ Time Frame: Measured at 16 Weeks ]
- Chest Cavity Size [ Time Frame: 16 Weeks ]
- Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: 16 Weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201123
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 |
Principal Investigator: | William Rom, MD, MPH | NYU School of Medicine |
Publications of Results:
Responsible Party: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00201123 History of Changes |
Other Study ID Numbers: |
264 R01HL059832-06 ( U.S. NIH Grant/Contract ) |
First Posted: | September 20, 2005 Key Record Dates |
Results First Posted: | June 10, 2014 |
Last Update Posted: | December 16, 2016 |
Last Verified: | December 2016 |
Additional relevant MeSH terms:
Tuberculosis AIDS-Related Complex Acquired Immunodeficiency Syndrome Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections HIV 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 |