This study will explore whether the strategies of episodic versus continuous fluconazole therapy in HIV-infected subjects with recurrent oropharyngeal candidiasis will differ both in terms of the frequency of infections and the frequency of fluconazole-resistant infections. This investigator-initiated, NIH-sponsored 'A' study is a Phase IV multicenter randomized, open-label study employing two fluconazole management strategies (episodic versus continuous suppression) for oropharyngeal candidiasis on the time to development of clinically significant fluconazole-refractory infections. 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 exposure. Subjects will be followed for two years after the last subject has been enrolled. At randomization subjects will be stratified by baseline CD4+ count (0-49 cells/mm3 vs. 50-100 cells/mm3 vs. 101-150 cell/mm3). The design allows for increased dosing of continuous fluconazole for individuals with frequent infections or esophageal candidiasis on the continuous prophylaxis arm and continuous fluconazole prophylaxis for those initially assigned to episodic therapy who experience frequent oropharyngeal or esophageal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush.
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