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

Sponsor:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00043355

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 II

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:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Interferon gamma-1b Gamma Rays Interferons

U.S. FDA Resources

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:

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

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:

Mycobacterium avium-intracellulare Infection
Mycobacterium Infections, Atypical
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferon-gamma

Interferon-gamma, Recombinant
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012