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

Launched by PFIZER · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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
• 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 \< 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.