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

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.

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

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.