Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

Sponsor

National Jewish Health (Other)

Overall Status

Completed

CT.gov ID

NCT00004689

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.

Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.
Determine the safety and tolerance of amithiozone with chronic dosing in these patients.
Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellulare Infection	Drug: amithiozone Drug: clarithromycin Drug: ethambutol Drug: rifampin Drug: streptomycin	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 1991

Study Completion Date :

Sep 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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