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)

Completed · Not applicable

Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections

In brief

To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.

Key facts

Study ID

NCT00002090

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• 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.

You may not qualify if…

• Co-existing Condition:
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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