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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001318 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy Mycobacterium Infections, Atypical |
Drug: interferon gamma |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 1992 |
| Estimated Study Completion Date: | November 2000 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
| Study ID Numbers: | 920255, 92-I-0255 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001318 History of Changes |
| Health Authority: | United States: Federal Government |
|
Immune Adjuvant Phagocytes Non-tuberculous Mycobacterial Infection |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Interferon Type II Antineoplastic Agents Interferons Infection Antiviral Agents |
Pharmacologic Actions Mycobacterium Infections, Atypical Actinomycetales Infections Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Interferon-gamma, Recombinant |
