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

Tuberculosis Clinical Trial

Official title:

Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201123
• Other study ID #: 264
• Secondary ID: R01HL059832-06
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: December 14, 2016
• Start date: April 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS-Related Complex
• Tuberculosis

Intervention

Drug:
• Aerosol Interferon-Gamma
Participants will receive aerosol interferon-gamma.
• Subcutaneous interferon-gamma
Patients will receive subcutaneous interferon-gamma

Other:
• Placebo

Locations

Country	Name	City	State
South Africa	The Lung Institute at University of Cape Town	Cape Town
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum Conversion		Measured at 16 Weeks	No
Secondary	Chest Cavity Size		16 Weeks	No
Secondary	Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels		16 Weeks	No