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

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002306
  Purpose

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Fluconazole

MedlinePlus related topics:   AIDS    Meningitis   

ChemIDplus related topics:   Amphotericin B    Fluconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002306

Locations
United States, Alabama
Univ of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35294
United States, District of Columbia
George Washington Univ Med Ctr    
      Washington, District of Columbia, United States, 20037
United States, Florida
Univ of South Florida    
      Tampa, Florida, United States, 33612
United States, Georgia
Med College of Georgia    
      Augusta, Georgia, United States, 30912
Emory Univ School of Medicine    
      Atlanta, Georgia, United States, 30303
United States, Massachusetts
Univ Hosp    
      Boston, Massachusetts, United States, 02118
United States, Michigan
Ann Arbor Veterans Administration Med Ctr    
      Ann Arbor, Michigan, United States, 48105
United States, Missouri
Washington Univ School of Medicine    
      St. Louis, Missouri, United States, 63108
United States, New York
Saint Luke's - Roosevelt Hosp Ctr    
      New York, New York, United States, 10025
Bronx Veterans Administration / Mount Sinai Hosp    
      Bronx, New York, United States, 10468
United States, Ohio
Cincinnati Veterans Adm Med Ctr / Univ Hosp    
      Cincinnati, Ohio, United States, 452670405
United States, Texas
Univ TX San Antonio Health Science Ctr    
      San Antonio, Texas, United States, 78284
Southwest Texas Methodist Hosp    
      San Antonio, Texas, United States, 78229
United States Air Force Med Ctr    
      Lackland Air Force Base, Texas, United States, 782365300

Sponsors and Collaborators
Pfizer
  More Information


Study ID Numbers:   012I, 056-161
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002306
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Meningitis  
Cryptococcosis  
Fluconazole
Acquired Immunodeficiency Syndrome
Amphotericin B

Study placed in the following topic categories:
Fluconazole
Abelcet
Amphotericin B
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Central Nervous System Diseases
Immunologic Deficiency Syndromes
Meningitis
Virus Diseases
Mycoses
Central Nervous System Infections
HIV Infections
AmBisome
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Meningitis, Cryptococcal
Cryptococcosis
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Meningitis, Fungal
Antiprotozoal Agents
Slow Virus Diseases
Immune System Diseases
Nervous System Diseases
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Lentivirus Infections
Central Nervous System Fungal Infections
Amebicides

ClinicalTrials.gov processed this record on October 07, 2008




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