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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 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
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   32   32   32 
Did Not Meet Continuation Criteria   2   0   5 
COMPLETED   26   28   23 
NOT COMPLETED   6   4   9 



  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.
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
  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]
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% 
Gender 
[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
  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
e-mail: William.Rom@nyumc.org


Publications of Results:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov 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