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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004689
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

February 24, 2000
February 25, 2000
March 25, 2015
January 1991
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Complete list of historical versions of study NCT00004689 on Archive Site
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Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
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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

Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Mycobacterium Avium-intracellulare Infection
  • Drug: amithiozone
  • Drug: clarithromycin
  • Drug: ethambutol
  • Drug: rifampin
  • Drug: streptomycin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 1998
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--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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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National Jewish Health
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Study Chair: Charles Arthur Peloquin National Jewish Health
FDA Office of Orphan Products Development
February 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP