Skip to main content
OpenTrials
Completed

NCT Number: NCT00201123

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis AIDS-Related Complex Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Lung Institute at University of Cape Town, Cape Town, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aerosol interferon-gamma

Drug

Participants will receive aerosol interferon-gamma.

Subcutaneous interferon-gamma

Drug

Patients will receive subcutaneous interferon-gamma

Placebo

Other

Primary outcomes

  1. Sputum Conversion

    Time frame: Measured at 16 Weeks

Secondary outcomes

  1. Chest Cavity Size

    Time frame: 16 Weeks

  2. Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels

    Time frame: 16 Weeks

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.