A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

June 23, 2005 updated by: Pharmacia
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

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
      • Phoenix, Arizona, United States, 85010
        • Maricopa County Med Ctr
    • California
      • Harbor City, California, United States, 90710
        • Bay Harbor Hosp
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
      • Los Angeles, California, United States, 90028
        • Southwest Community Based AIDS Treatment Group - COMBAT
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • San Diego, California, United States, 92102
        • HIV Research Group
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Administration Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Administration Med Ctr
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Ctr for Special Immunology
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Hollywood, Florida, United States, 33021
        • Mem Hosp Hollywood
      • Miami, Florida, United States, 33125
        • Miami Veterans Administration Med Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30076
        • Infectious Disease Research Consortium of Georgia
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Dr Frank Rhame
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Med Ctr
    • New Jersey
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • East Meadow, New York, United States, 11554
        • Nassau County Med Ctr
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr / Saint Vincent's Hosp
    • 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

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).
  • Didanosine (ddI).

Patients must have the following:

  • Diagnosis of AIDS as defined by the CDC.
  • Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
  • Provide written informed consent.

Prior Medication:

Allowed:

  • If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
  • Required:
  • Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to any of the study drugs.

Concurrent Medication:

Excluded:

  • Other therapy for mycobacterial disease.

Patients with the following are excluded:

  • Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

  • Therapy for mycobacterial disease.
  • Antiretroviral drugs, other than zidovudine (AZT) or ddI.
  • Investigational drugs, other than ddI.

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

November 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 048C
  • CS 087065

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.

Clinical Trials on HIV Infections

Clinical Trials on Rifabutin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe