Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
2 other identifiers
interventional
89
2 countries
2
Brief Summary
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedResults Posted
Study results publicly available
June 10, 2014
CompletedDecember 16, 2016
December 1, 2016
1.8 years
September 16, 2005
January 22, 2014
December 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sputum Conversion
Measured at 16 Weeks
Secondary Outcomes (2)
Chest Cavity Size
16 Weeks
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
16 Weeks
Study Arms (3)
Standard Treatment
PLACEBO COMPARATORIsoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
Aerosol Interferon-gamma
EXPERIMENTALAerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Subcutaneous Interferon-Gamma
EXPERIMENTALSubcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Interventions
Participants will receive aerosol interferon-gamma.
Patients will receive subcutaneous interferon-gamma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NYU School of Medicine
New York, New York, 10016, United States
The Lung Institute at University of Cape Town
Cape Town, South Africa
Related Publications (1)
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.
PMID: 19753300RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Rom MD
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
William Rom, MD, MPH
NYU School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
April 1, 2005
Primary Completion
January 1, 2007
Study Completion
August 1, 2007
Last Updated
December 16, 2016
Results First Posted
June 10, 2014
Record last verified: 2016-12