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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00001911 |
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Date of registration:
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03/11/1999 |
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Primary sponsor: |
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Public title:
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Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections
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Scientific title:
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Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections |
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Date of first enrolment:
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July 1999 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001911 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Severe disseminated or pulmonary nontuberculous mycobacterial infection refractory to the
best tolerated conventional therapy in addition to IFN gamma delivered for at least 3
months. This infection must have been proven by culture at some point during the illness.
At the time of enrollment, patients will be eligible if they have negative cultures but
histopathologic, examinable, or radiographic evidence of ongoing infection.
In vitro responsiveness to IL-12 as demonstrated by augmentation of peripheral blood
mononuclear cell (PBMC) phytohemagglutinin (PHA) induced IFN gamma production.
Women of childbearing age must have a negative pregnancy test (urine or serum) at the time
of starting the study and agree to take measures to avoid pregnancy throughout the study
while receiving IL-12. Males will be advised that the effects of IL-12 on sperm are not
well-known, and they should avoid conception during the study period.
Age 18 years or over.
Adequate hematopoietic, renal and hepatic function, defined as:
Absolute neutrophil count greater than or equal to 1000/microL (G-CSF permitted);
Hemoglobin greater than or equal to 9 g/dl (transfusion or erythropoietin permitted);
Platelet count greater than or equal to 100,000/microL;
Creatinine less than or equal to 1.5 X upper limit of normal;
Bilirubin less than or equal to 1.5 X upper limit of normal;
AST/SGOT less than or equal to 2.5 X upper limit of normal;
ALT/SGPT less than or equal to 2.5 X upper limit of normal;
Calculated Creatinine Clearance greater than 60 mL/min.
Karnofsky Performance Status index greater than or equal to 70.
Written signed informed consent.
No HIV infection.
No active malignancy.
No symptomatic cardiac disease or ongoing treatment for same.
No active seizure disorder or ongoing treatment for same.
No pregnancy or lactation.
No surgery during the two weeks prior to the start of IL-12.
No concurrent use of systematic corticosteroids, except for physiologic replacement.
No exposure to any investigational drug within four weeks prior to the start of dosing.
No gastrointestinal bleeding or uncontrolled peptic ulcer disease.
No history of inflammatory bowel disease or autoimmune disease such as rheumatoid
arthritis or systemic lupus erythematosus.
No other major illness which, in the investigator's judgement, will substantially increase
the risk associated with the patient's participation in this study.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atypical Mycobacterium Infection
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Intervention(s)
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Drug: Interleukin-12
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Secondary ID(s)
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99-I-0147
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990147
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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