The efficacy of fluconazole 600 mg/day versus itraconazole 600 mg/day as consolidation therapy of cryptococcal meningitis in AIDS patients

Abstract

Cryptococcal meningitis is one of the major complications affecting the central nervous system of patients suffering from AIDS. The results of treatment, when following current recommendation are still unsatisfactory.

Objective: This study aimed to evaluate the efficacy of a higher than recommended dose of oral fluconazole and itraconazole as consolidation therapy for cryptococcal meningitis in AIDS patients.

Design and method: HIV infected patients with primary cryptococcal meningitis, who had been treated initially with amphotericin B for 2 weeks were included in this study. They were randomized into two groups, to receive either fluconazole 600 mg daily or itraconazole 600 mg daily for 10 weeks. The response towards the two different treatments was clinically defined to be successful, if after 10 weeks of treatment no clinical symptoms and signs of meningitis remained and the cerebrospinal fluid (CSF) fungal culture was negative.

Results: The trial was performed from April 1999 to April 2000 at Srinagarind Hospital, Khon Kaen, Thailand. At the beginning of the trial 44 cases were selected, but only 35 patients proved to be suitable for the final evaluation of the study. Out of those, 19 cases were assigned to the fluconazole and 16 cases to the itraconazole group. Ten weeks after treatment, all patients clinically recovered completely. The CSF sterilization rate for the fluconazole group and for the itraconazole group were 100 and 94 per cent respectively. The Fisher's exact test showed no significant difference in the CSF sterilization rate between both groups (p = 0.26).

Conclusion: The result of this study indicates that treatment with either 600 mg per day of fluconazole or itraconazole as consolidation treatment have the same efficacy for AIDS patients suffering from cryptococcal meningitis. The results of this study also suggest, comparing the result of this trial with the results of similar trials published somewhere else, that treatment with the higher doses may be superior to treatment regimens using lower doses, as can be judged from the clinical outcome and the results of the mycological cultures.