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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00201123
First received: September 16, 2005
Last updated: December 2, 2015
Last verified: December 2015
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
No text entered.

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
  Description
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   30   32   27 
Not Eligible for Clinical Trial   2   0   5 
COMPLETED   26   28   23 
NOT COMPLETED   4   4   4 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
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 
Age 
[Units: Years]
Mean (Standard Deviation)
 32  (11)   34  (10)   35  (13)   34  (10) 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   30   32   27   89 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   10   8   9   27 
Male   20   24   18   62 
Region of Enrollment 
[Units: Participants]
       
South Africa   30   32   27   89 


  Outcome Measures

1.  Primary:   Sputum Conversion   [ Time Frame: Measured at Week 4 ]

2.  Secondary:   Chest CT Scan   [ Time Frame: Measured at Month 4 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels   [ Time Frame: Measured at Month 4 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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