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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004689
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: February 1999

February 24, 2000
March 24, 2015
January 1991
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Complete list of historical versions of study NCT00004689 on ClinicalTrials.gov 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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 1998
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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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004689
199/13311, NJCIRM-HS-750, NJCIRM-FDR000812
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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