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

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Demographic information provided for all subjects who were eligible for the study after all screening procedures were performed. 7 subjects who were found to be ineligible after randomization but prior to administration of treatment (listed as "did not meet continuation criteria" in participant flow section) are not included in baseline analysis.

Reporting Groups
DOTS Control Group

IRPE Anti-Tuberculous Therapy

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: Participants will receive subcutaneous interferon-gamma.

Total Total of all reporting groups

Baseline Measures
   DOTS Control Group   Aerosol Interferon Gamma for TB   Subcutaneous Interferon Gamma for TB   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   32   27   89 
[Units: Years]
Mean (Standard Deviation)
 32  (11)   34  (10)   35  (13)   34  (10) 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      32 100.0%      27 100.0%      89 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
[Units: Participants]
Count of Participants
Female      10  33.3%      8  25.0%      9  33.3%      27  30.3% 
Male      20  66.7%      24  75.0%      18  66.7%      62  69.7% 
Region of Enrollment 
[Units: Participants]
South Africa   30   32   27   89 

  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