Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy; Mycobacterium Infections, Atypical
Intervention: interferon gamma (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Clinical Details
Official title: Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Study design: Treatment, Safety/Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland 20892, United States
Additional Information
Related 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.
Starting date: August 1992
Ending date: November 2000
Last updated: March 3, 2008
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