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Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

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ClinicalTrials.gov Identifier: NCT00001318
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Mycobacterium Infections, Atypical Drug: interferon gamma Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Primary Purpose: Treatment
Official Title: Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma
Study Start Date : August 1992
Study Completion Date : November 2000

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001318


Locations
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United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00001318     History of Changes
Other Study ID Numbers: 920255
92-I-0255
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: August 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Immune Adjuvant
Phagocytes
Non-tuberculous Mycobacterial Infection

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents