Mycobacterium Avium-intracellulare Infection Clinical Trial
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00000883 -
Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy
|
N/A | |
Completed |
NCT00111397 -
Adjuvant Cytokine Therapy to Treat Pulmonary Mycobacterium Avium Complex Infection
|
Phase 1 | |
Completed |
NCT00021567 -
A Randomized, Double-Blinded, Placebo-Controlled, Phase II Inhaled Interferon Gamma-1b and Antimycobacterials to Treat Pulmonary Mycobacterium Avium Complex Infections
|
Phase 2 | |
Completed |
NCT00001763 -
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
|
Phase 1 | |
Recruiting |
NCT05824988 -
Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease
|
||
Completed |
NCT00002104 -
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
|
Phase 1 | |
Completed |
NCT00001039 -
Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
|
Phase 2 | |
Completed |
NCT00001030 -
The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
|
Phase 3 | |
Completed |
NCT00002080 -
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study
|
N/A | |
Completed |
NCT00002343 -
A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
|
Phase 4 | |
Completed |
NCT00001023 -
The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients
|
N/A | |
Completed |
NCT00002090 -
An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)
|
N/A | |
Completed |
NCT00002037 -
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
|
N/A | |
Completed |
NCT00002140 -
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
|
Phase 3 | |
Completed |
NCT00002170 -
A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
|
Phase 2 | |
Completed |
NCT00002309 -
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
|
N/A | |
Completed |
NCT00002032 -
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
|
N/A | |
Completed |
NCT00002058 -
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
|
N/A | |
Completed |
NCT00002085 -
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
|
N/A | |
Completed |
NCT00002089 -
An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
|
N/A |