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)
NCT ID: NCT00002090
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Azithromycin
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Medications allowed under a Treatment IND program.
Patients must have:
* HIV infection.
* Disseminated Mycobacterium avium Complex.
* Fever (\> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
* Life expectancy of at least the duration of the study.
* Consent of parent or guardian if below the legal age of consent.
Exclusion Criteria
Patients with the following symptoms and conditions are excluded:
* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy).
Prior Medication:
Excluded:
* Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
* Any other antibiotic with known activity against M. avium within 7 days prior to study entry.
Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Beth Israel Hosp
Boston, Massachusetts, United States
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Countries
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Other Identifiers
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066-148
Identifier Type: -
Identifier Source: secondary_id
058H
Identifier Type: -
Identifier Source: org_study_id