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
3 other identifiers
interventional
N/A
1 country
24
Brief Summary
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (24)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Dr Milton Estes
Mill Valley, California, 94941, United States
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, 94609, United States
UCI Med Ctr
Orange, California, 92668, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699, United States
Pfizer Central Research
Groton, Connecticut, 06340, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Med Service
Miami, Florida, 33125, United States
Dr Robert Wallace
St. Petersburg, Florida, 33713, United States
Bay Area AIDS Consortium
Tampa, Florida, 33609, United States
West Paces Clinical Research Inc
Atlanta, Georgia, 30327, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Dr Neel French / Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640, United States
Oschner Clinic
New Orleans, Louisiana, 70121, United States
Trinity Lutheran Hosp / Infectious Disease Clinic
Kansas City, Missouri, 64108, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, 77009, United States
Dr Gary Brewton
Houston, Texas, 77027, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Related Publications (1)
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.
PMID: 11073759BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-07