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

December 14, 2016 updated by: NYU Langone Health

Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa
        • The Lung Institute at University of Cape Town
  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard Treatment
Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
Other: Placebo
Experimental: Aerosol Interferon-gamma
Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Drug: Aerosol Interferon-Gamma
Participants will receive aerosol interferon-gamma.
Experimental: Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Drug: Subcutaneous interferon-gamma
Patients will receive subcutaneous interferon-gamma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sputum Conversion
Time Frame: Measured at 16 Weeks
Measured at 16 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Chest Cavity Size
Time Frame: 16 Weeks
16 Weeks
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: William Rom, MD, MPH, NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264
  • R01HL059832-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe