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

Condition(s) targeted: Tuberculosis; AIDS-Related Complex

Intervention: IRPE Anti-Tuberculous Therapy (Drug); Aerosol Interferon-Gamma (Drug); Subcutaneous Interferon-Gamma (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

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

Official title: Host Response to TB and AIDS

Study design: Treatment, Randomized

Primary outcome: Sputum conversion (measured at Weeks 4 and 8)

Secondary outcome:

Chest CT scan

BAL to measure flow of cytometry and cytokine levels (measured at Month 4)

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization

- CD4+ 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

The Lung Institute at University of Cape Town, Cape Town, South Africa

NYU School of Medicine, New York, New York 10016, United States

Starting date: April 2005
Last updated: May 14, 2007