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

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: Tuberculosis; AIDS-related Complex

Treatments: Other: Placebo; Drug: Subcutaneous interferon-gamma; Drug: Aerosol Interferon-Gamma

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00201123

264

R01HL059832-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 3 patient groups, including a placebo group

Standard Treatment

Placebo Comparator group

Description:

Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy

Treatment:

Other: Placebo

Aerosol Interferon-gamma

Experimental group

Description:

Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Treatment:

Drug: Aerosol Interferon-Gamma

Subcutaneous Interferon-Gamma

Experimental group

Description:

Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Treatment:

Drug: Subcutaneous interferon-gamma