Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
NCT ID: NCT00002076
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Fluconazole
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States
Cornell Univ Med Ctr
New York, New York, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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056-162
Identifier Type: -
Identifier Source: secondary_id
012J
Identifier Type: -
Identifier Source: org_study_id