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| Sponsored by: |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 100 |
| Study Start Date: | December 2000 |
| Study Completion Date: | February 2003 |
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 |
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 More Information
| Study ID Numbers: | GIMAC-001 |
| Study First Received: | August 7, 2002 |
| Last Updated: | October 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00043355 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
pulmonary mycobacterium avium complex infection MAC |
nontuberculous mycobacteria lung |
|
Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Gram-Positive Bacterial Infections Interferon Type II Interferons |
Mycobacterium Infections Antiviral Agents Mycobacterium Avium Complex Infection Mycobacterium Infections, Atypical Interferon-gamma, Recombinant Mycobacterium avium-intracellulare Infection |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Interferon Type II Antineoplastic Agents Interferons Infection Antiviral Agents |
Pharmacologic Actions Mycobacterium Infections, Atypical Actinomycetales Infections Mycobacterium avium-intracellulare Infection Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Interferon-gamma, Recombinant |
