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

Phase 2

Completed

• Conditions: Tuberculosis; AIDS-related Complex
• Interventions: Other: Placebo; Drug: Aerosol Interferon-Gamma; Drug: Subcutaneous interferon-gamma

• Registration Number: NCT00201123
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Primary Completion: 2007-01
• Study Completion: 2007-08
• Results First Submitted: 2014-01-22
• Results First Submitted QC: 2014-06-09
• Results First Posted: 2014-06-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Placebo	Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
Aerosol Interferon-gamma	Aerosol Interferon-Gamma	Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Subcutaneous Interferon-Gamma	Subcutaneous interferon-gamma	Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Primary Outcome Measures

Name	Time	Method
Sputum Conversion	Measured at 16 Weeks

Secondary Outcome Measures

Name	Time	Method
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels	16 Weeks
Chest Cavity Size	16 Weeks

Trial Locations

Locations (2)

The Lung Institute at University of Cape Town; 🇿🇦 Cape Town, South Africa

NYU School of Medicine; 🇺🇸 New York, New York, United States