Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Meningitis, Cryptococcal, HIV Infections
About this trial
This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B
Eligibility Criteria
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.
Sites / Locations
- Univ of Alabama at Birmingham
- Tucson Veterans Administration Med Ctr
- Dr Richard Meyer
- Davies Med Ctr
- Dr Paul Rothman
- Wilmington Hosp / Med Ctr of Delaware
- George Washington Univ Med Ctr
- Univ of Florida College of Medicine
- Univ of South Florida
- Emory Univ School of Medicine
- Med College of Georgia
- DeKalb Gen Hosp
- Shallowford Hosp
- Northwestern Univ Med School
- Dr Michael Bach
- Univ of Maryland / Inst of Human Virology
- New England Med Ctr
- Univ Hosp
- Ann Arbor Veterans Administration Med Ctr
- Harper Hosp
- Henry Ford Hosp
- Saint Michael's Med Ctr
- Albany Med College / AIDS Treatment Ctr
- Jewish Hosp Ctr Affiliation
- Cabrini Med Ctr
- Chelsea Village Med Ctr
- Columbia Univ
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
- Bowman Gray School of Medicine / North Carolina Baptist Hosp
- Cincinnati Veterans Adm Med Ctr / Univ Hosp
- Buckley Braffman Stern Med Associates
- Univ TX Galveston Med Branch
- United States Air Force Med Ctr
- Southwest Texas Methodist Hosp
- Univ TX San Antonio Health Science Ctr
- Richmond AIDS Consortium
- CHG-118 Group Health / Cooperative of Puget Sound
- Dr Philip C Craven
- Saint Michael's Hosp