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

Mycobacterium Avium-intracellulare Infection Clinical Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycobacterium Avium-intracellulare Infection
• Mycobacterium Infections

• NCT number: NCT00004689
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: Phase 2
• Start date: January 1991
• Completion date: September 1998