Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-08-31

Study Completion Date

2000-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Mycobacterium Infections, Atypical

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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interferon gamma

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No