HIV Infections, Meningitis, Cryptococcal
Conditions
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B
Brief summary
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
Interventions
DRUGFluconazole
DRUGAmphotericin B
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Antivirals such as zidovudine. * Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). * Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry. 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 neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry. * Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy. * Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry. Prior Medication: Allowed: * Antivirals such as 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: * Ketoconazole. * Fluconazole. * Itraconazole. * Miconazole. * Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. * 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. * Inability to take oral medications reliably. Prior Medication: Excluded: * Ketoconazole. * Fluconazole. * Itraconazole. * Miconazole. * Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. * Intrathecal amphotericin B. * Coumarin-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. Prior Treatment: Excluded: * Lymphocyte replacement.
Countries
Canada, United States
Outcome results
None listed