Search / Trial NCT00002306

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

Launched by PFIZER · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Aids Related Opportunistic Infections Meningitis Cryptococcosis Fluconazole Acquired Immunodeficiency Syndrome Amphotericin B

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • * Immunosuppressant therapy.
  • * Antiviral therapy such as zidovudine.
  • * Prophylaxis for Pneumocystis carinii pneumonia.
  • * Aerosolized pentamidine.
  • Concurrent Treatment:
  • Allowed:
  • * Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.
  • * Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
  • * Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
  • * Each individual patient must be approved by Pfizer Central Research prior to study entry.
  • Prior Medication:
  • Allowed:
  • * Immunosuppressant therapy.
  • * Antiviral therapy such as zidovudine.
  • * Prophylaxis for Pneumocystis carinii pneumonia.
  • * Aerosolized pentamidine.
  • 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 or azoles.
  • * Moderate or severe liver disease.
  • 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 or azoles.
  • * Moderate or severe liver disease.
  • * Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
  • * Life expectancy of \< 2 weeks.
  • Prior Medication:
  • Excluded:
  • * Coumadin-type anticoagulants.
  • * Oral hypoglycemics.
  • * Barbiturates.
  • * Phenytoin.
  • * Immunostimulants.
  • * Investigational drugs or approved (licensed) drugs for investigational indications.
  • Prior Treatment:
  • Excluded:
  • * Lymphocyte replacement.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

Birmingham, Alabama, United States

Washington, District Of Columbia, United States

Bronx, New York, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Boston, Massachusetts, United States

New York, New York, United States

San Antonio, Texas, United States

Ann Arbor, Michigan, United States

Cincinnati, Ohio, United States

Lackland Air Force Base, Texas, United States

San Antonio, Texas, United States

St. Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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