ACTG 323 FLUCONAZOLE AS THERAPY FOR OROPHARYNGEAL CANDIDIASIS

University Of Colorado Denver, Aurora CO

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Abstract

This study will explore treatment strategies in HIV-infected individuals who have recurrent oropharyngeal candidiasis. It will explore using fluconazole only when infection is present (episodic) versus continuous fluconazole therapy to see if there is a difference in terms of frequency of infections and frequency of fluconazole-resistant infections. This investigator-initiated, National Institute of Health sponsored, multicenter Phase IV study to compare the effects that management strategies, episodic versus continuous suppression, have on oropharyngeal candidiasis before the development of clinically significant fluconazole-refractory infections, infections that are unresponsive to treatment. Subjects to be enrolled are those with an active episode of oropharyngeal candidiasis or subjects with a history of at least one prior episode of oropharyngeal candidiasis within the last six months and CD4+ count < 150 cells/mm3 without prior extensive azole, family of antifungal drugs used to treat candida, exposure. Subjects will be followed for two years after the last subject has been enrolled to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. The design allows for increased dosing of continuous fluconazole for individuals with frequent infections or esophageal candidiasis and continuous fluconazole treatment for those initially assigned to episodic therapy who experience frequent oropharyngeal or esophageal candidiasis.