Status:
COMPLETED
Interferon Gamma for Drug Resistant Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia
Pulmonary Tuberculosis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will determine what dose of recombinant interferon-gamma is safe and effective for treating multiple drug-resistant tuberculosis. Recombinant interferon-gamma is a genetically engineered fo...
Detailed Description
This is a phase I/II, controlled, open label, dose escalation study to determine the tolerance, toxicity, and clinical effect of the administration of interferon-gamma on the clinical condition and im...
Eligibility Criteria
ELIGIBLITY CRITERIA:
Clinical and microbiologic/histologic demonstration of MDRTB, either disseminated (i.e. infection at 2 or more non-contiguous sites) or pulmonary.
Preserved renal function (creatinine less than or equal to 2 mg/100 ml; less than or equal to 2+ proteinuria).
Preserved hepatic function (bilirubin less than or equal to 1.5 mg/100 ml; prothrombin time less than or equal to 1.3x control).
Preserved hematologic function (WBC greater than or equal to 3000/mm3; granulocytes greater than 1500/mm3; platelets greater than or equal to 100,000/mm3).
Patients of childbearing potential may be entered if using effective contraception and having a negative serum or urine HCG within one week of beginning therapy.
EXCLUSION CRITERIA:
Presence of causes of secondary immunodeficiency such as HIV or malignancy.
Currently receiving cytotoxic therapy, or have received it within the last 3 months.
Pregnant or lactating women may not be entered.
Patients with a known seizure disorder may not be entered.
Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease may not be entered.
Patients unable, in the judgment of the PI, to comply with the treatment regimen will be excluded.
Key Trial Info
Start Date :
May 1 1994
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00001407
Start Date
May 1 1994
End Date
May 1 2003
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892