Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

June 23, 2005 updated by: Pfizer
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Saint Michael's Hosp
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Tucson Veterans Administration Med Ctr
    • California
      • Los Angeles, California, United States, 90048
        • Dr Richard Meyer
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • Sherman Oaks, California, United States, 91403
        • Dr Paul Rothman
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Wilmington Hosp / Med Ctr of Delaware
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Gainesville, Florida, United States, 32610
        • Univ of Florida College of Medicine
      • Tampa, Florida, United States, 33612
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory Univ School of Medicine
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
      • Decatur, Georgia, United States, 30033
        • DeKalb Gen Hosp
      • Decatur, Georgia, United States, 30033
        • Shallowford Hosp
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Maine
      • Portland, Maine, United States, 04102
        • Dr Michael Bach
    • Maryland
      • Baltimore, Maryland, United States, 212011192
        • Univ of Maryland / Inst of Human Virology
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr
      • Boston, Massachusetts, United States, 02118
        • Univ Hosp
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Ann Arbor Veterans Administration Med Ctr
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Harper Hosp
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Med Ctr
    • New York
      • Albany, New York, United States, 12203
        • Albany Med College / AIDS Treatment Ctr
      • Jamaica, New York, United States, 11432
        • Jewish Hosp Ctr Affiliation
      • New York, New York, United States, 10037
        • Harlem AIDS Treatment Group / Harlem Hosp Ctr
      • New York, New York, United States, 10014
        • Chelsea Village Med Ctr
      • New York, New York, United States, 10032
        • Columbia Univ
      • New York, New York, United States, 10003
        • Cabrini Med Ctr
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Bowman Gray School of Medicine / North Carolina Baptist Hosp
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Cincinnati Veterans Adm Med Ctr / Univ Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch
      • Lackland Air Force Base, Texas, United States, 782365300
        • United States Air Force Med Ctr
      • San Antonio, Texas, United States, 78229
        • Southwest Texas Methodist Hosp
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
    • Washington
      • Seattle, Washington, United States, 98112
        • CHG-118 Group Health / Cooperative of Puget Sound
      • Tacoma, Washington, United States, 98405
        • Dr Philip C Craven

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:

  • Antivirals such as zidovudine.
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
  • Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must be oriented to person, place, and time, and able to give written informed consent.

  • Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry.
  • Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy.
  • Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry.

Prior Medication:

Allowed:

  • Antivirals such as zidovudine (AZT).
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.

Concurrent Medication:

Excluded:

  • Ketoconazole.
  • Fluconazole.
  • Itraconazole.
  • Miconazole.
  • Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
  • Intrathecal amphotericin B.
  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Inability to take oral medications reliably.

Prior Medication:

Excluded:

  • Ketoconazole.
  • Fluconazole.
  • Itraconazole.
  • Miconazole.
  • Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
  • Intrathecal amphotericin B.
  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

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

May 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012D
  • 056-157

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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