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Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
NYU School of Medicine
New York, New York, United States
The Lung Institute at University of Cape Town
Cape Town, South Africa
Start Date
April 1, 2005
Primary Completion Date
January 1, 2007
Completion Date
August 1, 2007
Last Updated
December 16, 2016
89
ACTUAL participants
Aerosol Interferon-Gamma
DRUG
Subcutaneous interferon-gamma
DRUG
Placebo
OTHER
Lead Sponsor
NYU Langone Health
Collaborators
NCT06192160
NCT05947890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05989802