Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

• Status: Completed
• Trial end date: 2000-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interferon-gamma; Interferons

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.