Not Signed In -
Mycobacterium Avium Complex/mac |
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Clinical Trial: Treatment of Non-Tuberculous Mycobacterial Infections with Interferon Gamma
This study has been completed.
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Purpose
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.
| Condition | Phase |
|---|---|
| Healthy Mycobacterium Infections, Atypical | Phase II |
MedlinePlus related topics: Bacterial Infections
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy
Expected Total Enrollment: 60
Study start: August 30, 1992; Study completion: November 29, 2000
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.
Eligibility
Genders Eligible for Study: Both
Criteria
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.
Location Information
Maryland
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
More Information
Publications
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.
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. Review.
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.
Record last reviewed: August 18, 1999
Last Updated: December 11, 2002
Record first received: November 3, 1999
ClinicalTrials.gov Identifier: NCT00001318
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Simple Facts Sheets: MAC (AIDS Treatment Data Network)
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