The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

January 15, 2015 updated by: Abbott

A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3

To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Univ of Arizona / Health Science Ctr
    • California
      • Fresno, California, United States, 93726
        • California Med Research Group
      • San Diego, California, United States, 92102
        • HIV Research Group
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Med Ctr
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
      • San Jose, California, United States, 951282699
        • Santa Clara Valley Med Ctr
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Hollywood, Florida, United States, 33021
        • Dr Nelson Zide
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Hosp
    • New York
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
      • Syracuse, New York, United States, 13210
        • SUNY / Health Sciences Ctr at Syracuse
      • Valhalla, New York, United States, 10595
        • New York Med College / Westchester County Med Ctr
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • San Antonio, Texas, United States, 78284
        • Audie L Murphy Veterans Administration Hosp
    • Virginia
      • Salem, Virginia, United States, 24153
        • Salem Veterans Administration Med Ctr
    • Washington
      • Tacoma, Washington, United States, 98405
        • Dr Alan D Tice / Infections Ltd

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 count <= 100 cells/mm3.
  • No evidence of MAC.
  • Life expectancy of at least 6 months.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Certain restricted drugs (details not available).

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.

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

Abbott

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 Major Dates

Study Start

November 1, 1992

Primary Completion (Actual)

November 1, 1994

Study Completion (Actual)

November 1, 1994

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)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124A
  • M91-561

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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