Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Primary Purpose
Healthy, Mycobacterium Infections, Atypical
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interferon gamma
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Immune Adjuvant, Phagocytes, Non-tuberculous Mycobacterial Infection
Eligibility Criteria
Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary. Received medical treatment for at least 3 months without improvement. Preserved renal, hepatic and hematologic function. Negative pregnancy urine and effective contraceptive. Age range greater than 5. No secondary immunodeficiency such as HIV or malignancy. Not currently receiving cytotoxic therapy within the past 3 months. Not pregnant or lactating. No seizure disorders. No known symptomatic cardiac disease.
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001318
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001318
Brief Title
Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Official Title
Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Study Type
Interventional
2. Study Status
Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
August 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.
Detailed Description
This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mycobacterium Infections, Atypical
Keywords
Immune Adjuvant, Phagocytes, Non-tuberculous Mycobacterial Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon gamma
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary.
Received medical treatment for at least 3 months without improvement.
Preserved renal, hepatic and hematologic function.
Negative pregnancy urine and effective contraceptive.
Age range greater than 5.
No secondary immunodeficiency such as HIV or malignancy.
Not currently receiving cytotoxic therapy within the past 3 months.
Not pregnant or lactating.
No seizure disorders.
No known symptomatic cardiac disease.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3086725
Citation
Nathan CF, Kaplan G, Levis WR, Nusrat A, Witmer MD, Sherwin SA, Job CK, Horowitz CR, Steinman RM, Cohn ZA. Local and systemic effects of intradermal recombinant interferon-gamma in patients with lepromatous leprosy. N Engl J Med. 1986 Jul 3;315(1):6-15. doi: 10.1056/NEJM198607033150102.
Results Reference
background
PubMed Identifier
3880852
Citation
Horsburgh CR Jr, Mason UG 3rd, Farhi DC, Iseman MD. Disseminated infection with Mycobacterium avium-intracellulare. A report of 13 cases and a review of the literature. Medicine (Baltimore). 1985 Jan;64(1):36-48. doi: 10.1097/00005792-198501000-00003.
Results Reference
background
PubMed Identifier
7908719
Citation
Holland SM, Eisenstein EM, Kuhns DB, Turner ML, Fleisher TA, Strober W, Gallin JI. Treatment of refractory disseminated nontuberculous mycobacterial infection with interferon gamma. A preliminary report. N Engl J Med. 1994 May 12;330(19):1348-55. doi: 10.1056/NEJM199405123301904.
Results Reference
background
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Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
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