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
  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: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Host Response to TB and AIDS

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Sputum conversion (measured at Weeks 4 and 8)

Secondary Outcome Measures:
  • Chest CT scan
  • BAL to measure flow of cytometry and cytokine levels (measured at Month 4)

Estimated Enrollment: 96
Study Start Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201123

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
South Africa
The Lung Institute at University of Cape Town
Cape Town, South Africa
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201123     History of Changes
Other Study ID Numbers: 264, R01 HL059832
Study First Received: September 16, 2005
Last Updated: May 14, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Tuberculosis
Tuberculosis, Pulmonary
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014