A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

June 23, 2005 updated by: Pharmacia
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Study Type

Interventional

Enrollment

450

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
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • McDowell Clinic
      • Phoenix, Arizona, United States, 85008
        • Maricopa Med Research Foundation
    • California
      • Harbor City, California, United States, 90710
        • Bay Harbor Hosp
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Los Angeles, California, United States, 90028
        • Combat Group
      • Oakland, California, United States, 946021018
        • Highland Gen Hosp / San Francisco Gen Hosp
      • San Diego, California, United States, 92102
        • HIV Research Group
      • San Diego, California, United States, 92103
        • UCSD / Ctr for Special Immunology
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
      • Sunnyvale, California, United States, 94086
        • Sunnyvale Med Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Infectious Disease Consultants
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Fort Lauderdale, Florida, United States, 33316
        • Dr Frank Tornaka
      • Hollywood, Florida, United States, 33021
        • Dr Nelson Zide
      • Miami Beach, Florida, United States, 33140
        • Ctr for Special Immunology
      • Safety Harbor, Florida, United States, 34695
        • Dr Barry Rodwick
      • Tampa, Florida, United States, 33609
        • Bay Area AIDS Consortium
    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Infectious Disease Research Consortium of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Dr Daniel Berger
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ Med School
    • Michigan
      • Keego Harbor, Michigan, United States, 48320
        • Dr Arnold Markowitz
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr / HIV Clinic
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • East Orange Veterans Administration Med Ctr
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • New Hyde Park, New York, United States, 11042
        • Long Island Jewish Med Ctr
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr / Saint Vincent's Hosp
      • Rochester, New York, United States, 14620
        • Community Health Network
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Polyclinic Med Ctr
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • South Carolina
      • Charleston, South Carolina, United States, 294015799
        • Charleston Veterans Administration Med Ctr
      • Columbia, South Carolina, United States, 29204
        • Dr Alfred F Burnside Jr
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Univ of Wisconsin School of Medicine
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee County Med Complex

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

Concurrent Medication:

Allowed:

  • Isoniazid for TB prophylaxis ONLY.

Patients must have:

  • HIV infection.
  • MAC infection.
  • Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Perceived unreliability or unavailability for frequent monitoring.

Concurrent Medication:

Excluded:

  • Antimycobacterial drugs other than the study drugs.
  • Carbamazepine.
  • Terfenadine.
  • Theophylline.

Patients with the following prior condition are excluded:

History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.

Prior Medication:

Excluded within 7 days prior to study entry:

  • Rifabutin.
  • Rifampin.
  • Ethionamide.
  • Cycloserine.
  • Clofazimine.
  • Ethambutol.
  • Amikacin.
  • Ciprofloxacin.
  • Ofloxacin.
  • Sparfloxacin.
  • Azithromycin.
  • Clarithromycin.
  • Pyrazinamide.

Excluded within 14 days prior to study entry:

  • Carbamazepine.
  • Terfenadine.
  • Theophylline.

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

Pharmacia

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

June 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 048D
  • CS 087250-999

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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