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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.
 
ClinicalTrials.gov Identifier: NCT00201123
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 10, 2014
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

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
Enrollment 89
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Hide Arm/Group Description

DOTS Control Group

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.

Period Title: Overall Study
Started 32 32 32
Did Not Meet Continuation Criteria 2 0 5
Completed 26 28 23
Not Completed 6 4 9
Arm/Group Title DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB Total
Hide Arm/Group Description

IRPE Anti-Tuberculous Therapy

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma.

Total of all reporting groups
Overall Number of Baseline Participants 30 32 27 89
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 27 participants 89 participants
32  (11) 34  (10) 35  (13) 34  (10)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 27 participants 89 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 27 participants 89 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  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 30 participants 32 participants 27 participants 89 participants
30 32 27 89
1.Primary Outcome
Title Sputum Conversion
Hide Description [Not Specified]
Time Frame Measured at 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Arm/Group Title DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Hide Arm/Group Description:

IRPE Anti-Tuberculous Therapy

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.

Overall Number of Participants Analyzed 30 32 27
Measure Type: Number
Unit of Measure: percentage of participants
36 60 36
2.Secondary Outcome
Title Chest Cavity Size
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Arm/Group Title DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Hide Arm/Group Description:

IRPE Anti-Tuberculous Therapy

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma.

Overall Number of Participants Analyzed 32 30 27
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline 34  (11) 39  (24) 34  (13)
16 Weeks 20  (16) 29  (24) 18  (17)
3.Secondary Outcome
Title Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Hide Description [Not Specified]
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Arm/Group Title DOTS Nebulized rlFN-y Subcutaneous rlFN-y
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 32 27
Median (Inter-Quartile Range)
Unit of Measure: cells/mL
Lymphocytes Week 0
4
(2 to 8)
5
(3 to 15)
6
(3 to 10)
Lymphocytes Week 16
15
(6 to 25)
15
(8 to 34)
22
(13 to 33)
Machrophages Week 0
60
(17 to 84)
60
(32 to 80)
62
(43 to 83)
Machrophages Week 16
64
(44 to 72)
63
(40 to 84)
66
(54 to 77)
Neutrophils Week 0
28
(10 to 82)
24
(5 to 56)
30
(4 to 54)
Neutrophils Week 16
11
(3 to 31)
4
(2 to 16)
2
(2 to 9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Hide Arm/Group Description

DOTS Control Group

IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.

Aerosol Interferon-Gamma

Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.

All-Cause Mortality
DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   3/32 (9.38%)   3/27 (11.11%) 
Respiratory, thoracic and mediastinal disorders       
hemoptysis  1/30 (3.33%)  0/32 (0.00%)  0/27 (0.00%) 
Desaturation on BAL  0/30 (0.00%)  2/32 (6.25%)  2/27 (7.41%) 
pneumonia  0/30 (0.00%)  1/32 (3.13%)  1/27 (3.70%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DOTS Control Group Aerosol Interferon Gamma for TB Subcutaneous Interferon Gamma for TB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/32 (0.00%)   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Rom MD
Organization: NYU School of Medicine
Phone: 212 263-6479
EMail: William.Rom@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00201123    
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