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 provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.
Mycobacterium Avium-Intracellulare Infection
Drug : Azithromycin
Primary Purpose: Treatment
|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)|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Medications allowed under a Treatment IND program.
- 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.
- 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).
- 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
Patients must have:
Patients with the following symptoms and conditions are excluded:
Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002090
Locations Show More
|United States, Massachusetts|
|Beth Israel Hosp|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Bronx Veterans Affairs Med Ctr|
|Bronx, New York, United States, 10468|
|SUNY / Health Sciences Ctr at Syracuse|
|Syracuse, New York, United States, 13210|
|United States, Ohio|
|Ohio State Univ Hosp|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|United States Air Force Med Ctr|
|Lackland Air Force Base, Texas, United States, 78236|
|Audie L Murphy Veterans Administration Hosp|
|San Antonio, Texas, United States, 78284|
Sponsors and CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002090 History of Changes|
|Other Study ID Numbers:||058H|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on May 24, 2019
This information is provided by ClinicalTrials.gov.