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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2007 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00201123

First received: September 16, 2005

Last updated: May 14, 2007

Last verified: May 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	September 16, 2005
Last Updated Date	May 14, 2007
Start Date ^ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 6, 2006)	Sputum conversion (measured at Weeks 4 and 8)
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00201123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 6, 2006)	Chest CT scan BAL to measure flow of cytometry and cytokine levels (measured at Month 4)
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Official Title ^ICMJE	Host Response to TB and AIDS
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Primary Purpose: Treatment
Condition ^ICMJE	Tuberculosis AIDS-Related Complex
Intervention ^ICMJE	Drug: IRPE Anti-Tuberculous Therapy Drug: Aerosol Interferon-Gamma Drug: Subcutaneous Interferon-Gamma
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	96
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, South Africa

Administrative Information
NCT Number ^ICMJE	NCT00201123
Other Study ID Numbers ^ICMJE	264, R01 HL059832
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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