PHASE IV RANDOMIZED STUDY OF FLUCONAZOLE AS CHRONIC SUPPRESSIVE THERAPY

$0M01FY2000RRNIH

Indiana Univ-Purdue Univ At Indianapolis, Indianapolis IN

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Abstract

This study is a multicenter, prospective, phase IV, randomized, open-label study of the use of fluconazole comparing two long-term management strategies for oropharyngeal candidiasis. 948 HIV-infected persons with a CD4 count of < 150 cells/mm3 and at least one prior episode of oropharyngeal candidiasis (OPC) within 6 months prior to study entry will be randomized. The primary study objective is to compare the effects of management strategies using episodic fluconazole therapy versus continuous fluconazole prophylaxis for oropharyngeal candidiasis on the time to development of clinically significant fluconazole-refractory infections.

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