Efficacy of fluconazole in cryptococcal meningitis

Abstract

In this clinical trial, oral fluconazole was used to treat cryptococcal meningitis in 32 patients with Acquired Immune Deficiency Syndrome (AIDS). In 11 patients who received 200 to 400 mg/day of fluconazole as primary therapy, a favorable clinical response was obtained in 67% of all evaluable patients. A negative cerebrospinal fluid (CSF) culture was also reported for 86% of these cases. Fluconazole was used as second-line therapy in an additional 15 patients who were not responsive to therapy with amphotericin B or amphotericin B combined with flucytosine. Positive clinical and mycologic responses were then obtained in more than 60% of these cases. Following successful treatment with fluconazole as either the primary or secondary antifungal agent, 26 patients were evaluated during maintenance therapy with 100 to 200 mg daily of fluconazole to prevent recurrence of disease. The relapse rate was 3.2 cases of cryptococcal meningitis per 1000 patient weeks, with a mean duration of 22 weeks for maintenance therapy. An additional six patients who were also treated with either amphotericin B alone or in combination with flucytosine but were asymptomatic or CSF culture negative when treatment with fluconazole was initiated were evaluated for the safety and efficacy of maintenance therapy. Thus, treatment of fluconazole appears to be efficacious as well as safe. The incidence of superimposed infections associated in these AIDS patients make it difficult to accurately assess any adverse effects.