HIV Infections, Meningitis, Cryptococcal
Conditions
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Administration, Oral, Acquired Immunodeficiency Syndrome
Brief summary
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.
Interventions
DRUGFluconazole
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed