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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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