Expired Study
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Los Angeles, California 90033


Purpose:

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Immunosuppressant therapy. - Antiviral such as zidovudine. - Radiation therapy for mucocutaneous Kaposi's sarcoma. - Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol 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. - Relapse after prior therapy. - 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: - Immunosuppressant therapy. - Antivirals such as zidovudine (AZT). - Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol 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. - Comatose. - Unlikely to survive more than 2 weeks. - Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. Concurrent Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. - Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. - Excluded within 4 weeks of study entry: - Received more than 1 mg/kg/wk amphotericin B. 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, azoles, or amphotericin B. - Moderate or severe liver disease. - Comatose. - Unlikely to survive more than 2 weeks. Prior Medication: Excluded: - Coumadin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications. - Excluded within 4 weeks of study entry: - More than 1 mg/kg/wk amphotericin B. Prior Treatment: Excluded: - Lymphocyte replacement.


NCT ID:

NCT00002075


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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