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Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
This study has been completed.
Sponsor:
New York University School of Medicine
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 14, 2016
Last verified: December 2016
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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:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Sputum Conversion [ Time Frame: Measured at 16 Weeks ]
Secondary Outcome Measures:
- Chest Cavity Size [ Time Frame: 16 Weeks ]
- Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: 16 Weeks ]
| Enrollment: | 89 |
| 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) |
| 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
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
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:
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00201123 History of Changes |
| Other Study ID Numbers: |
264 R01HL059832-06 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | September 16, 2005 |
| Results First Received: | January 22, 2014 |
| Last Updated: | December 14, 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 |
ClinicalTrials.gov processed this record on June 23, 2017