This multicenter, randomized, double-blind study compared the efficacy and safety of itraconazole oral solution and fluconazole tablets in the treatment of esophageal candidiasis. One hundred twenty-six immunocompromised patients with esophageal candidiasis were treated with itraconazole oral solution or fluconazole tablets (both at 100-200 mg) once daily for 3-8 weeks, for 2 weeks beyond the resolution of symptoms, and were then followed for 4 more weeks. Severity of symptoms was assessed weekly during treatment and every 2 weeks during follow-up. Patients treated with itraconazole oral solution had a rate of clinical response (cured or improved) comparable to that of patients treated with fluconazole (94% vs. 91%). The mycologic eradication rate was 92% for itraconazole and 78% for fluconazole. Both treatments were well tolerated. Results from treatment with once-daily itraconazole oral solution was clinically comparable to those with fluconazole and is an alternative for the treatment of esophageal candidiasis in immunocompromised patients.