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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.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002140
  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 III

MedlinePlus related topics:   AIDS   

Drug Information available for:   Azithromycin    Ethambutol hydrochloride    Ethambutol    Clarithromycin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
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

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
Infectious Disease Med Group / Adult Immunology Clinic    
      Oakland, California, United States, 94609
Santa Clara Valley Med Ctr    
      San Jose, California, United States, 951282699
UCI Med Ctr    
      Orange, California, United States, 92668
Dr Milton Estes    
      Mill Valley, California, United States, 94941
Kaiser Permanente Med Ctr    
      San Francisco, California, United States, 94115
East Bay AIDS Ctr    
      Berkeley, California, United States, 94705
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
Bay Area AIDS Consortium    
      Tampa, Florida, United States, 33609
Dr Robert Wallace    
      St. Petersburg, Florida, United States, 33713
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
Dr Gary Brewton    
      Houston, Texas, United States, 77027
Univ of Texas Southwestern Med Ctr of Dallas    
      Dallas, Texas, United States, 75235
Austin Infectious Disease Consultants    
      Austin, Texas, United States, 78705
Thomas Street Clinic / Baylor College of Medicine    
      Houston, Texas, United States, 77009
Central Texas Med Foundation    
      Austin, Texas, United States, 78751
United States, Virginia
Hampton Roads Med Specialists    
      Hampton, Virginia, United States, 23666

Sponsors and Collaborators
Pfizer
  More Information


Publications:

Study ID Numbers:   226B, 066-189, 189/189B
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002140
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

Study placed in the following topic categories:
Bacterial Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection
Virus Diseases
Clarithromycin
Gram-Positive Bacterial Infections
HIV Infections
Azithromycin
Sexually Transmitted Diseases
Mycobacterium Infections
Ethambutol
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Actinomycetales Infections
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on November 20, 2008




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