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

Conditions: Meningitis, Cryptococcal; HIV Infections

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.


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.

Keywords: aids-related opportunistic infections meningitis cryptococcosis fluconazole acquired immunodeficiency syndrome amphotericin b