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

Launched by PFIZER · Aug 30, 2001

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Eligibility criteria

• • 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:
• • A minimum total amphotericin B dose of 2 grams as monotherapy.
• • 6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram.
• • After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks).
• • For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.
• • Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy.
• Prior Medication:
• Allowed:
• • Antiviral therapy (e.g., zidovudine (AZT)).
• • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
• • 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.
• • Barbiturates.
• • Phenytoin.
• • Immunostimulants.
• • Investigational drugs or approved (licensed) drugs for investigational indications.
• Concurrent Treatment:
• Excluded:
• • Lymphocyte replacement.
• 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 defined by specific lab values.
• • Inability to take oral medications reliably.
• Prior Medication:
• Excluded:
• • Intrathecal amphotericin B.
• • Coumarin-type anticoagulants.
• • Oral hypoglycemics.
• • Barbiturates.
• • Phenytoin.
• • Immunostimulants.
• • Investigational drugs or approved (licensed) drugs for investigational indications.
• Prior Treatment:
• Excluded:
• • Lymphocyte replacement.