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Open, Non-Comparative Study of Intravenous and 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: NCT00002040
  Purpose

To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.


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, Open Label
Official Title: Open, Non-Comparative Study of Intravenous and 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:

  • Antivirals 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.

  • Patient's treatment status must be one of the following:
  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy. The success of prior therapy must have been documented by negative 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 the study.

Prior Medication:

Allowed:

  • Antivirals such as zidovudine (AZT). 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.
  • A history of allergy to or intolerance of imidazoles or azoles.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy of < 2 weeks.

Concurrent Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • A history of allergy to or intolerance of imidazoles or azoles.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy of < 2 weeks.

Prior Medication:

Excluded:

  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002040

Locations
United States, California
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
United States, Illinois
Cook County Hosp
Chicago, Illinois, United States, 60612
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Pfizer
  More Information

Study ID Numbers: 012L, 056-164A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002040  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Meningitis
Injections, Intravenous
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 16, 2009