Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

NCT00001318 | Completed Phase 2

• 2 other identifiers: 92025592-I-0255
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Mycobacterium Infections, Atypical

Keywords

Immune Adjuvant; Phagocytes; Non-tuberculous Mycobacterial Infection

Interventions

interferon gamma DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1056/NEJM198607033150102.

  PMID: 3086725 BACKGROUND

• 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. doi: 10.1097/00005792-198501000-00003.

  PMID: 3880852 BACKGROUND

• 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. doi: 10.1056/NEJM199405123301904.

  PMID: 7908719 BACKGROUND

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: August 1, 1992
• Study Completion: November 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-08

Locations

US (1)