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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
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

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

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

Detailed Description:


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.


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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sputum Conversion [ Time Frame: Measured at 16 Weeks ]

Secondary Outcome Measures :
  1. Chest Cavity Size [ Time Frame: 16 Weeks ]
  2. 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, Older Adult)
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

Information from the National Library of Medicine

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

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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
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: William Rom, MD, MPH NYU School of Medicine
Publications of Results:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00201123    
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:
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AIDS-Related Complex
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents