A comparison of itraconazole versus fluconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. National Institute of Allergy and Infectious Diseases Mycoses Study Group [see comments]

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Clin Infect Dis. 1999 Feb;28(2):291-6. Unique Identifier : AIDSLINE MED/99162009
Saag MS; Cloud GA; Graybill JR; Sobel JD; Tuazon CU; Johnson PC; Fessel WJ; Moskovitz BL; Wiesinger B; Cosmatos D; Riser L; Thomas C; Hafner R; Dismukes WE; Department of Medicine, Comprehensive Cancer Center, University; of Alabama School of Medicine at Birmingham 35294-2050, USA.; msaag@uab.edu

Abstract: This study was designed to compare the effectiveness of fluconazole vs. itraconazole as maintenance therapy for AIDS-associated cryptococcal meningitis. HIV-infected patients who had been successfully treated (achieved negative culture of CSF) for a first episode of cryptococcal meningitis were randomized to receive fluconazole or itraconazole, both at 200 mg/d, for 12 months. The study was stopped prematurely on the recommendation of an independent Data Safety and Monitoring Board. At the time, 13 (23%) of 57 itraconazole recipients had experienced culture-positive relapse, compared with 2 relapses (4%) noted among 51 fluconazole recipients (P = .006). The factor best associated with relapse was the patient having not received flucytosine during the initial 2 weeks of primary treatment for cryptococcal disease (relative risk = 5.88; 95% confidence interval, 1.27-27.14; P = .04). Fluconazole remains the treatment of choice for maintenance therapy for AIDS-associated cryptococcal disease. Flucytosine may contribute to the prevention of relapse if used during the first 2 weeks of primary therapy.

Keywords: CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL Adult Antifungal Agents/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY/IMMUNOLOGY Comparative Study Cryptococcosis/*DRUG THERAPY/IMMUNOLOGY Double-Blind Method Female Fluconazole/ADVERSE EFFECTS/*THERAPEUTIC USE Human Itraconazole/ADVERSE EFFECTS/*THERAPEUTIC USE Male Meningitis, Fungal/*DRUG THERAPY/IMMUNOLOGY Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. Treatment Outcome
Comment in: Clin Infect Dis 1999 Feb;28(2):297-8
990830
A9980948

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