Mycobacterium Avium-intracellulare Infection Clinical Trial
OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium
avium complex (MAC) pulmonary disease.
II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC
infection.
III. Determine the safety and tolerance of amithiozone with chronic dosing in these
patients.
IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol,
kanamycin, and amithiozone in the treatment of pulmonary MAC infection.
PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen
of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I
patients receive rifampin and ethambutol. Arm II patients receive amithiozone.
Patients are followed for one year to detect any relapse or other complications.
Patients not eligible for this randomized study may be entered on a short open label study
with amithiozone.
Completion date provided represents the completion date of the grant per OOPD records
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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