Treatment of Multiply Drug Resistant Tuberculosis With Interferon Gamma: A Phase I/II Dose Escalation Trial

Date de début de l'étude : 1 mai 1994

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.