Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study.

The aim of this study was to assess the role and the therapeutic efficacy of 2 azole antifungal drugs, fluconazole and itraconazole, in the treatment of endoscopically diagnosed Candida esophagitis in patients with acquired immunodeficiency syndrome (AIDS). The study involved 123 human immunodeficiency virus (HIV)-positive patients (70 males and 53 females, mean age 27 years) at their first episode of esophageal candidiasis diagnosed by endoscopy. The patients were randomized in a double-blind design to receive either fluconazole (100 mb b.i.d. per os) or itraconazole (100 mg b.i.d. per os). In order to evaluate the efficacy of treatment, clinical examinations were performed every week up to the end of follow-up (2 months); endoscopic examination was performed at baseline, at the end of treatment (3 weeks) and at the end of follow-up. At the end of the treatment, cure, as judged by endoscopy, was observed in 74% of fluconazole-treated patients and in 47.2% of itraconazole-treated patients (p < 0.01); at the end of follow-up, cure was observed endoscopically in 71.7% of fluconazole-treated patients and in 43.2% of the itraconazole-treated patients (p <0.05). As regards clinical cure, no statistically significant difference was observed between the groups, at the end of pharmacological treatment and at the end of follow-up. The results of this study demonstrate that both fluconazole and itraconazole are efficacious in the treatment of Candida esophagitis in AIDS patients; fluconazole is associated with higher rate of endoscopic cure than is itraconazole.