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Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical research trials and Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease. Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease clinical trial. Participants frequently obtain the most expert healthcare available for their Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease  Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
For Condition: Mycobacterium avium-intracellulare Infection
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , National Jewish Center for Immunology and Respiratory Medicine
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
CharlesPeloquin, Study Chair, National Jewish Center for Immunology and Respiratory Medicine
Additional Information:
Study ID Numbers: 199/13311; NJCIRM-HS-750,NJCIRM-FDR000812
Study Start Date: January 1991
Record last reviewed: February 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004689
Other Mycobacterium Avium-Intracellulare Infection Studies:
1. Evaluation of the Therapeutic Benefit of r-metHuIFN- gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
2. The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children with AIDS
3. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
4. Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
5. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
Related Studies:
Other Mycobacterium avium-intracellulare Infection Clinical Trials
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Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
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