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Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
This study has been completed.
Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002076
  Purpose

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.


Condition Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Fluconazole

MedlinePlus related topics: AIDS Meningitis
Drug Information available for: Fluconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study of Oral Fluconazole in the Treatment of 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:

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

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.
  • 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:

  • 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, azoles, or amphotericin B.
  • Moderate or severe liver disease defined by specified lab values.
  • Patients who are unable to take oral medication.
  • Unlikely to survive more than 2 weeks.
  • Renal impairment.

Concurrent Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
  • Excluded within 4 weeks of study entry:
  • Greater than 1 mg/kg/wk amphotericin B.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

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 defined by specified lab values.
  • Patients who are unable to take oral medication.
  • Life expectancy of < 2 weeks.
  • Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

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

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002076

Locations
United States, California
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Pfizer
  More Information

Study ID Numbers: 012J, 056-162
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002076  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Fluconazole
Opportunistic Infections
Meningitis, Fungal
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
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Meningitis, Cryptococcal
Cryptococcosis
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Nervous System Diseases
Lentivirus Infections
Central Nervous System Fungal Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009