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Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptococcal Meningitis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

- 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.

NCT00002076
Pfizer
Completed
Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

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Pfizer Clinical Trials Contact Center

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[email protected]

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