Interferon Gamma for Drug Resistant Tuberculosis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

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 immune function of patients with multiply drug resistant M. tuberculosis infections (MDRTB). The study drug (interferon gamma) will be administered subcutaneously three times a week at three dose levels (0.025 mg/m(2), 0.05 mg/m(2), 0.1 mg/m(2)) for one year in addition to anti-tuberculous medications, as determined by in vitro sensitivities.

Gender

ALL

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.