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

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002068
  Purpose

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


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Fluconazole
Drug: Amphotericin B

MedlinePlus related topics:   AIDS    Meningitis   

ChemIDplus related topics:   Amphotericin B    Fluconazole    Flucytosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
  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.

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.

Concurrent Medication:

Excluded within 4 weeks of study entry:

  • Greater than 1 mg/kg/wk amphotericin B.
  • Coumadin-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:

  • 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 within 4 weeks of study entry:

  • Greater than 1 mg/kg/wk amphotericin B.
  • 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: NCT00002068

Locations
United States, California
Davies Med Ctr    
      San Francisco, California, United States, 94114
United States, Delaware
Christiana Hosp / Med Ctr of Delaware    
      Wilmington, Delaware, United States, 19899
United States, Florida
Univ of South Florida    
      Tampa, Florida, United States, 33612
United States, Maryland
Univ of Maryland / Inst of Human Virology    
      Baltimore, Maryland, United States, 212011192
United States, Michigan
Henry Ford Hosp    
      Detroit, Michigan, United States, 48202
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr    
      New York, New York, United States, 10037
United States, Tennessee
Univ of Tennessee    
      Memphis, Tennessee, United States, 38163
Canada, Ontario
Saint Michael's Hosp    
      Toronto, Ontario, Canada

Sponsors and Collaborators
Pfizer
  More Information


Study ID Numbers:   012H, 056-159B
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002068
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Meningitis  
Cryptococcosis  
Drug Therapy, Combination  
Fluconazole
Flucytosine
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
Flucytosine
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 September 16, 2008




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