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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Rom, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00201123
First received: September 16, 2005
Last updated: June 9, 2014
Last verified: May 2014
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

  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
No text entered.

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  
Number of Participants  
[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


  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
e-mail: William.Rom@nyumc.org


Publications of Results:

Responsible Party: William Rom, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00201123     History of Changes
Other Study ID Numbers: 264, R01HL059832-06
Study First Received: September 16, 2005
Results First Received: January 22, 2014
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration