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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS | Clinical Trials | Clareo Health

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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

NCT00002294•Pfizer

View on ClinicalTrials.gov

Summary

To compare the safety and effectiveness of fluconazole with that of placebo as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Concurrent Medication:
•Allowed:
•Antiviral therapy (e.g., zidovudine).
•Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
•Concurrent Treatment:
•Allowed:
•Radiation therapy for mucocutaneous Kaposi's sarcoma.
•Patients must be oriented to person, place, and time and able to give written informed consent.
•Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.
•Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include:
+9 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with the following are excluded:
•Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
•History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
•Moderate or severe liver disease.
•Concurrent Medication:
•Excluded:
•Intrathecal amphotericin B.
•Coumarin-type anticoagulants.
•Oral hypoglycemics.
+24 more criteria

Locations (5)

Dr Robert Larsen

Los Angeles, California, United States

UCI Med Ctr

Orange, California, United States

UCSD

San Diego, California, United States

Dr Paul Rothman

Sherman Oaks, California, United States

Stanford Univ School of Medicine

Stanford, California, United States

Key Dates

Last Updated

June 24, 2005

Conditions

Meningitis, CryptococcalHIV Infections

Interventions

Fluconazole

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS

Inclusion Criteria

Exclusion Criteria

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