A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
NCT ID: NCT00002140
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Ethambutol hydrochloride
Clarithromycin
Azithromycin
Eligibility Criteria
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Inclusion Criteria
* HIV seropositivity.
* Disseminated MAC.
* No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
* Life expectancy of at least 2 months.
* Consent of parent or guardian if below legal age of consent.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
* Inability to take oral medications.
* Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).
Concurrent Medication:
Excluded:
* Another investigational drug started in the week prior to study entry.
Prior Medication:
Excluded:
* MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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East Bay AIDS Ctr
Berkeley, California, United States
Dr Milton Estes
Mill Valley, California, United States
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, United States
UCI Med Ctr
Orange, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
Pfizer Central Research
Groton, Connecticut, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, United States
Med Service
Miami, Florida, United States
Dr Robert Wallace
St. Petersburg, Florida, United States
Bay Area AIDS Consortium
Tampa, Florida, United States
West Paces Clinical Research Inc
Atlanta, Georgia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Dr Neel French / Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Oschner Clinic
New Orleans, Louisiana, United States
Trinity Lutheran Hosp / Infectious Disease Clinic
Kansas City, Missouri, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Austin Infectious Disease Consultants
Austin, Texas, United States
Central Texas Med Foundation
Austin, Texas, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, United States
Dr Gary Brewton
Houston, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Countries
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References
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Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6.
Other Identifiers
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066-189
Identifier Type: -
Identifier Source: secondary_id
189/189B
Identifier Type: -
Identifier Source: secondary_id
226B
Identifier Type: -
Identifier Source: org_study_id