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

June 23, 2005 updated by: Pfizer
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..

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 226B
  • 066-189
  • 189/189B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Clarithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe