Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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):
New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Tuberculosis
AIDS-related Complex
Interventions: Drug: Aerosol Interferon-Gamma
Drug: Subcutaneous interferon-gamma
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
DOTS Control Group

DOTS Control Group

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon Gamma for TB

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon Gamma for TB

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.

Participant Flow:   Overall Study
    DOTS Control Group   Aerosol Interferon Gamma for TB   Subcutaneous Interferon Gamma for TB
STARTED   32   32   32 
Did Not Meet Continuation Criteria   2   0   5 
COMPLETED   26   28   23 
NOT COMPLETED   6   4   9 

  Baseline Characteristics

  Outcome Measures

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

2.  Secondary:   Chest Cavity Size   [ Time Frame: 16 Weeks ]

3.  Secondary:   Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels   [ Time Frame: 16 Weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: William Rom MD
Organization: NYU School of Medicine
phone: 212 263-6479

Publications of Results:

Responsible Party: New York University School of Medicine Identifier: NCT00201123     History of Changes
Other Study ID Numbers: 264
R01HL059832-06 ( U.S. NIH Grant/Contract )
First Submitted: September 16, 2005
First Posted: September 20, 2005
Results First Submitted: January 22, 2014
Results First Posted: June 10, 2014
Last Update Posted: December 16, 2016