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)
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Azithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
Summary
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the
treatment of Mycobacterium avium bacteremia in AIDS patients.
Clinical Details
Official title: 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)
Study design: Treatment, Dose Comparison, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Beth Israel Hosp, Boston, Massachusetts 02215, United States
SUNY / Health Sciences Ctr at Syracuse, Syracuse, New York 13210, United States
Bronx Veterans Affairs Med Ctr, Bronx, New York 10468, United States
Ohio State Univ Hosp, Columbus, Ohio 43210, United States
United States Air Force Med Ctr, Lackland Air Force Base, Texas 78236, United States
Audie L Murphy Veterans Administration Hosp, San Antonio, Texas 78284, United States
Additional Information
Last updated: June 23, 2005
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