- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002090
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)
June 23, 2005 updated by: Pfizer
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Hosp
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New York
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Bronx, New York, United States, 10468
- Bronx Veterans Affairs Med Ctr
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Syracuse, New York, United States, 13210
- SUNY / Health Sciences Ctr at Syracuse
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State Univ Hosp
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Texas
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Lackland Air Force Base, Texas, United States, 78236
- United States Air Force Med Ctr
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San Antonio, Texas, United States, 78284
- Audie L Murphy Veterans Administration Hosp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (ESTIMATE)
August 31, 2001
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 1996
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Slow Virus Diseases
- Mycobacterium Infections, Nontuberculous
- HIV Infections
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Mycobacterium avium-intracellulare Infection
- Anti-Infective Agents
- Anti-Bacterial Agents
- Azithromycin
Other Study ID Numbers
- 058H
- 066-148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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