Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

June 23, 2005 updated by: Pharmacia
The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

750

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Univ of Calgary Health Science Ctr
      • Edmonton, Alberta, Canada
        • Univ of Alberta/Division of Inf Dis/Dept of Med
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hosp
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Victoria Gen Hosp
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster Univ Med Ctr
      • Ottawa, Ontario, Canada
        • Ottawa Gen Hosp
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
      • Toronto, Ontario, Canada
        • Saint Michael's Hosp
      • Toronto, Ontario, Canada
        • Mount Sinai Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp
      • Montreal, Quebec, Canada
        • Dr Emil Toma / Hotel Dieu de Montreal
      • Montreal, Quebec, Canada
        • Montreal Chest Institute
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85010
        • Maricopa County Med Ctr
    • California
      • Berkeley, California, United States, 94704
        • East Bay AIDS Ctr
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Med Group
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • San Diego, California, United States, 92102
        • HIV Research Group
      • San Francisco, California, United States, 94115
        • Dr Marcus Conant
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp / HIV Care
      • San Francisco, California, United States, 94108
        • Dr Larry A Waites
      • Santa Rosa, California, United States, 95404
        • Dr Marshall Kubota
      • Tarzana, California, United States, 91356
        • Dr Jeffrey Galpin
    • Florida
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
      • Miami, Florida, United States, 33137
        • Community Research Initiative of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Comprehensive AIDS Alliance of Detroit / Harper Hosp
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
      • St Paul, Minnesota, United States, 55101
        • St Paul Ramsey Med Ctr
    • Nevada
      • Reno, Nevada, United States, 89520
        • Univ of Nevada / Veterans Administration Med Ctr
    • New Jersey
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
      • Sante Fe, New Mexico, United States, 87501
        • Dr Donald Romig
    • New York
      • Albany, New York, United States, 12208
        • Albany Veterans Administration
      • Buffalo, New York, United States, 14215
        • AIDS Services Erie County Med Ctr
      • Rochester, New York, United States, 14620
        • Community Health Network
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Med College
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Dr Alfred F Burnside Jr
    • Virginia
      • Annandale, Virginia, United States, 22203
        • Infectious Disease Physicians Inc
    • Wisconsin
      • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have the following:

  • Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
  • Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
  • Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.

Concurrent Medication:

Excluded:

  • Antiretroviral agents other than zidovudine (AZT).
  • Didanosine (ddI).
  • Antimycobacterial therapy.
  • Rifampin.
  • Isoniazid.
  • Clofazimine.
  • Ethambutol.
  • Cycloserine.
  • Ethionamide.
  • Amikacin.
  • Ciprofloxacin.
  • Streptomycin.
  • Other investigational drugs.
  • If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.

Patients with the following are excluded:

  • Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
  • Previous or current Mycobacterium avium complex (MAC) infection.
  • Perceived patient unreliability or unavailability for frequent monitoring.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
  • Antimycobacterial therapy.
  • Rifampin.
  • Isoniazid.
  • Clofazimine.
  • Ethambutol.
  • Cycloserine.
  • Ethionamide.
  • Amikacin.
  • Ciprofloxacin.

Required:

  • Zidovudine (AZT).
  • Antipneumocystis prophylactic therapy.

Required for at least 4 weeks prior to study entry:

  • Zidovudine (AZT) or didanosine (ddI).
  • Antipneumocystis prophylaxis.

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

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

March 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 048B
  • 087027-999

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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