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
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-intracellulare Infection; HIV Infections
Intervention: Ethambutol hydrochloride (Drug); Clarithromycin (Drug); Azithromycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer
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..
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Detailed description:
Patients are randomized to receive azithromycin at one of two doses in combination with
ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they
are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and
safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the
remaining 12 weeks.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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).
Locations and Contacts
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, District of Columbia 20007, United States
Whitman - Walker Clinic, Washington, 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
Dr Neel French / Louis A Weiss Memorial Hosp, Chicago, Illinois 60640, United States
Northwestern Univ Med School, Chicago, Illinois 60611, 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
Dr Gary Brewton, Houston, Texas 77027, United States
Thomas Street Clinic / Baylor College of Medicine, Houston, Texas 77009, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Additional Information
Related publications: Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White Jr AC, 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. Epub 2000 Nov 6. Erratum in: Clin Infect Dis 2001 May 1;32(9):1386.
Last updated: June 23, 2005
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