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NLM AIDSLINE
A double-blind, randomized study of weekly versus daily Fluconazole(FLU) for the prevention of fungal infections in AIDS 568 patients.
Havlir DV; Bozzette SA; McCutchan JA; Dunne M; University of California,
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:158. Unique

Daily fluconazole (FLU 200 mg) prophylaxis reduces the risk of deep fungal disease in HIV infected patients with CD4 cells less than 200/mm 3 , but the low incidence of serious fungal infections requires an estimated 11,756 doses of fluconazole to prevent each case (Powderly, et al. NE.JM 1995;332:700). To evaluate the effectiveness of less intensive antifungal prophylaxis, we conducted a double-blind, randomized study of weekly (400 mg) versus daily (200 mg) FLU. 636 AIDS patients with CD4 cell counts less than 100/3 were treated for a mean of 332 days. In the intent-to-treat analysis of the primary endpoint (deep fungal disease),17 (5.4%) events occurred in the FLU daily arm and 24 (7.6%) in the FLU weekly arm. [Risk ratio 1.49, 95% C.I. (0.79, 2.78)]. Dose limiting toxicity and survival were similar. (Table: See Text). Incidence of thrush was halved in the daily arm (28.4 episodes per 100 patient-1 years compared to the fluconazole weekly arm (63.7 episodes per 100 patient-years). The hazard ratio for the time to first episode of thrush was 0.49 [95% C.I. (0.37, 0.64)]. The 48 hour MIC90 for C. albicans isolates obtained from patients with thrush was 16 micrograms/mL in the daily fluconzole arm and 8 micrograms/mL in the weekly fluconazole arm. The distribution of MICs from available breakthrough isolates (n=25) did not differ significantly between groups. The prevalence of dermatophyte infections was significantly less on the daily regimen [RR=O.61, 95% C.I. (0.4, 0.94). Weekly fluconazole (400 mg) appears to provide similarly effective prophylaxis for deep fungal infections as the standard regimen (200 mg daily) employing 3.5 times as much drug (1400 mg weekly), but is less effective in suppressing thrush.

Acquired Immunodeficiency Syndrome/*COMPLICATIONS Antifungal Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Double-Blind Method Fluconazole/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Human Microbial Sensitivity Tests Mycoses/COMPLICATIONS/*PREVENTION & CONTROL ABSTRACT

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