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)
Mycobacterium Avium-Intracellulare Infection, HIV Infections
About this trial
This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Sites / Locations
- Beth Israel Hosp
- Bronx Veterans Affairs Med Ctr
- SUNY / Health Sciences Ctr at Syracuse
- Ohio State Univ Hosp
- United States Air Force Med Ctr
- Audie L Murphy Veterans Administration Hosp