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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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
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..

Condition Intervention Phase
Mycobacterium Avium-intracellulare Infection
HIV Infections
Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Drug: Azithromycin
Phase 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • Another investigational drug started in the week prior to study entry.

Prior Medication:


  • MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
  Contacts and Locations
Choosing 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 identifier: NCT00002140

United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Dr Milton Estes
Mill Valley, California, United States, 94941
Infectious Disease Med Group / Adult Immunology Clinic
Oakland, California, United States, 94609
UCI Med Ctr
Orange, California, United States, 92668
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Santa Clara Valley Med Ctr
San Jose, California, United States, 951282699
United States, Connecticut
Pfizer Central Research
Groton, Connecticut, United States, 06340
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Whitman - Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Med Service
Miami, Florida, United States, 33125
Dr Robert Wallace
St Petersburg, Florida, United States, 33713
Bay Area AIDS Consortium
Tampa, Florida, United States, 33609
United States, Georgia
West Paces Clinical Research Inc
Atlanta, Georgia, United States, 30327
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Dr Neel French / Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
United States, Louisiana
Oschner Clinic
New Orleans, Louisiana, United States, 70121
United States, Missouri
Trinity Lutheran Hosp / Infectious Disease Clinic
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Texas
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
Central Texas Med Foundation
Austin, Texas, United States, 78751
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, United States, 77009
Dr Gary Brewton
Houston, Texas, United States, 77027
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
  More Information

Publications: Identifier: NCT00002140     History of Changes
Other Study ID Numbers: 226B
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antitubercular Agents processed this record on May 25, 2017