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

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine Identifier:
First received: September 16, 2005
Last updated: December 14, 2016
Last verified: December 2016
Results First Received: January 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Tuberculosis
AIDS-related Complex
Interventions: Drug: Aerosol Interferon-Gamma
Drug: Subcutaneous interferon-gamma
Other: Placebo

  Participant Flow
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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
  Show All 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
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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
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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 ( US NIH Grant/Contract Award Number )
Study First Received: September 16, 2005
Results First Received: January 22, 2014
Last Updated: December 14, 2016