Objective: To assess the efficacy and tolerance of fluconazole (150 mg oral dose, once a week) in the prevention of recurrent oropharyngeal candidiasis in patients with moderate to severe human immunodeficiency virus (HIV) infection.
Design: A randomised, double-blind, placebo-controlled trial.
Patients: Eighty-four patients with moderate to severe HIV infection who had successfully completed two to four weeks treatment with fluconazole for oropharyngeal candidiasis were randomly allocated to receive either placebo or fluconazole. Pre-treatment clinical and laboratory characteristics were similar in the two groups.
Outcome measures: Success was classified as absence throughout the course of treatment of clinical evidence of oropharyngeal candidiasis, and failure as recurrence or relapse of symptomatic oropharyngeal candidiasis.
Results: Of 73 evaluable patients the median time to relapse was > or = 168 days in the fluconazole group and 37 days in the placebo group (P < 0.0001). One patient in the placebo group and 18 patients in the fluconazole group completed six months' treatment without clinical relapse (P < 0.001).
Conclusion: Fluconazole was well tolerated and prevented clinical relapse of oropharyngeal candidiasis in 71% of patients who completed three months of treatment (95% confidence interval [CI], 55-86) and 58% (95% CI, 41-75) who completed six months of treatment.