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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
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Immune Adjuvant, Phagocytes, Non-tuberculous Mycobacterial Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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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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