A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

June 23, 2005 updated by: Pfizer

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

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, 90095
        • UCLA CARE Ctr
      • San Francisco, California, United States, 94115
        • Dr Shelly Gordon
      • San Francisco, California, United States, 94120
        • Dr Martin Mass
      • Sherman Oaks, California, United States, 91403
        • Dr Paul Rothman
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Christiana Hosp / Med Ctr of Delaware
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School 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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State Univ School of Medicine
    • Maine
      • Portland, Maine, United States, 04102
        • Dr Michael Bach
    • Maryland
      • Baltimore, Maryland, United States, 212011192
        • Univ of Maryland / Inst of Human Virology
      • Baltimore, Maryland, United States, 21218
        • Loch Raven Veterans Hosp
    • 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
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • New York
      • Albany, New York, United States, 12203
        • Albany Med College / AIDS Treatment Ctr
      • Bronx, New York, United States, 10467
        • Montefiore Med Ctr / Bronx Municipal Hosp
      • Bronx, New York, United States, 10468
        • Bronx Veterans Administration / Mount Sinai Hosp
      • Jamaica, New York, United States, 11432
        • Jewish Hosp Ctr Affiliation
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10025
        • Saint Luke's - Roosevelt Hosp Ctr
      • 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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Cincinnati Veterans Adm Med Ctr / Univ Hosp
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ Hosp
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • Dr Daniel Barbaro
      • 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, 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

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:

  • Immunosuppressant therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy.
  • Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

  • Immunosuppressant therapy.
  • Antiviral therapy (such as zidovudine).
  • Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

  • Coumadin-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.
  • Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.
  • Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.

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

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

December 1, 1989

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012F
  • 056-159

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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