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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine

Study Description
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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:

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 Design
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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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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