Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

This study has been terminated.
(Futility)
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043355
First received: August 7, 2002
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex .

FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.


Condition Intervention Phase
Lung Infection
Drug: interferon gamma-1b
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection

Resource links provided by NLM:


Further study details as provided by InterMune:

Primary Outcome Measures:
  • sustained culture conversion [ Time Frame: 52 weeks ]

Enrollment: 100
Study Start Date: December 2000
Study Completion Date: February 2003
Intervention Details:
    Drug: interferon gamma-1b
    500 mcg, oral, three times weekly
Detailed Description:

Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible.

In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043355

Sponsors and Collaborators
InterMune
Investigators
Study Director: Steven Porter, MD InterMune
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043355     History of Changes
Other Study ID Numbers: GIMAC-001
Study First Received: August 7, 2002
Last Updated: October 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
pulmonary
mycobacterium avium complex infection
MAC
nontuberculous
mycobacteria
lung

Additional relevant MeSH terms:
Communicable Diseases
Infection
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Interferon-gamma
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014