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

Lung Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00043355
• Other study ID #: GIMAC-001
• Status: Terminated
• Phase: Phase 2
• First received: August 7, 2002
• Last updated: October 30, 2007
• Start date: December 2000
• Est. completion date: February 2003

Study information

• Verified date: October 2007
• Source: InterMune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lung Infection
• Mycobacterium avium-intracellulare Infection

Intervention

Drug:
• interferon gamma-1b
500 mcg, oral, three times weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InterMune

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained culture conversion		52 weeks