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

September 16, 2005
June 9, 2014
April 2005
January 2007   (final data collection date for primary outcome measure)
Sputum Conversion [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00201123 on ClinicalTrials.gov Archive Site
  • Chest CT Scan [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Tuberculosis
  • AIDS-related Complex
  • Drug: Aerosol Interferon-Gamma
    Participants will receive aerosol interferon-gamma.
  • Drug: Subcutaneous interferon-gamma
    Patients will receive subcutaneous interferon-gamma
  • Placebo Comparator: Standard Treatment
    Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
  • Experimental: Aerosol Interferon-gamma
    Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
    Intervention: Drug: Aerosol Interferon-Gamma
  • Experimental: Subcutaneous Interferon-Gamma
    Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
    Intervention: Drug: Subcutaneous interferon-gamma
Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
August 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
  • Cluster of Differentiation 4 greater than 200 if HIV positive
  • Ability to sign consent
  • Bilateral, cavitary pulmonary TB

Exclusion Criteria:

  • Multidrug-resistant (MDR) TB
  • Extrapulmonary TB
  • HIV positive with opportunistic infection within 30 days of study entry
  • Cancer
  • Asthma
  • Pregnant or lactating women
  • Chronic heart disease
  • Chronic liver disease
  • Chronic renal disease
  • Seizure disorder
  • Bleeding or clotting disorder
  • Diabetes mellitus
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa
 
NCT00201123
264, R01HL059832-06
Yes
William Rom, New York University School of Medicine
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: William Rom, MD, MPH NYU School of Medicine
New York University School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP