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.

Condition	Treatment or Intervention	Phase
Mycobacterium avium-intracellulare Infection	Drug: amithiozone  Drug: clarithromycin  Drug: ethambutol  Drug: rifampin  Drug: streptomycin	Phase II

Further Study Details: 

Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease
• Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin

--Prior/Concurrent Therapy--

• No likelihood of resectional thoracic surgery within 24 weeks of evaluation

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal
• Renal: Creatinine clearance at least 30 mL/min
• Cardiovascular: No New York Heart Association class III or IV heart failure
• Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing

Study chairs or principal investigators

Charles Arthur Peloquin,  Study Chair,  National Jewish Center for Immunology and Respiratory Medicine   

Study ID Numbers:  199/13311; NJCIRM-HS-750; NJCIRM-FDR000812
Record last reviewed:  February 1999
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004689
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08