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)

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National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States, 20892

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