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 objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.

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

  • United States
    • California
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
      • Sylmar, California, United States, 91342
        • Olive View Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Public Health Dept
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Ctr for Special Immunology
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Hollywood, Florida, United States, 33021
        • Mem Hosp Hollywood
      • Orlando, Florida, United States, 32806
        • VP Med Services / HHCS Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
      • Atlanta, Georgia, United States, 30335
        • Grady Memorial Hosp / Hughs Spalding Med Ctr
      • Roswell, Georgia, United States, 30076
        • Dr Winkler Weinberg
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Medicine
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • CRI of New England
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Univ of Missouri at Kansas City School of Medicine
      • Kansas City, Missouri, United States, 64132
        • Research Med Ctr
    • New York
      • Brooklyn, New York, United States, 11209
        • Brooklyn Veterans Administration
      • Brooklyn, New York, United States, 11219
        • Maimonides Med Ctr
      • East Meadow, New York, United States, 11554
        • Nassau County Med Ctr
      • New Hyde Park, New York, United States, 11042
        • Long Island Jewish Med Ctr
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr
      • New York, New York, United States, 10011
        • Community Research Initiative
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ Med Ctr
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Dallas, Texas, United States, 75219
        • Nelson Tebedo Community Clinic
      • El Paso, Texas, United States, 79905
        • Texas Tech Health Sciences Ctr
      • Houston, Texas, United States, 77005
        • Baylor College of Medicine
      • Houston, Texas, United States, 77266
        • Houston Clinical Research Network
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr
      • Temple, Texas, United States, 76508
        • Scott and White Hosp
      • Waco, Texas, United States, 76708
        • Dr Scott Lea

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.
  • Females of childbearing potential must also sign a special informed consent.

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

January 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 048A
  • 087023-999

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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