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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002140
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002140

Locations
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
Whitman - Walker Clinic
Washington, District of Columbia, United States, 20009
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
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
Central Texas Med Foundation
Austin, Texas, United States, 78751
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
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
Pfizer
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00002140     History of Changes
Other Study ID Numbers: 226B, 066-189, 189/189B
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Ethambutol
Azithromycin
Clarithromycin
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013