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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00201123 |
Purpose
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
| Condition | Intervention |
|---|---|
|
Tuberculosis AIDS-Related Complex |
Drug: IRPE Anti-Tuberculous Therapy Drug: Aerosol Interferon-Gamma Drug: Subcutaneous Interferon-Gamma |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Host Response to TB and AIDS |
| Estimated Enrollment: | 96 |
| Study Start Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 264, R01 HL059832 |
| Study First Received: | September 16, 2005 |
| Last Updated: | May 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00201123 |
| Health Authority: | United States: Federal Government |
|
Bacterial Infections Sexually Transmitted Diseases, Viral Interferon Type II Interferons Acquired Immunodeficiency Syndrome AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Gram-Positive Bacterial Infections Respiratory Tract Infections |
Respiratory Tract Diseases HIV Infections Tuberculosis, pulmonary Lung Diseases Tuberculosis, Pulmonary Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Retroviridae Infections Interferon-gamma, Recombinant |
|
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Lentivirus Infections Antiviral Agents Pharmacologic Actions Actinomycetales Infections |
