This double-blind trial compared the clinical and mycological efficacy and safety of itraconazole oral solution with those of fluconazole capsules in the treatment of oropharyngeal candidiasis in patients with AIDS. A total of 244 patients were enrolled and randomized to one of three groups for treatment with itraconazole oral solution (100 mg twice daily for 7 days or 100 mg once daily for 14 days) or fluconazole capsules (100 mg once daily for 14 days). Among 194 evaluable cases, complete response (clearance of all symptoms and signs) or marked improvement was noted in 54 of 60 patients (90%) receiving once-daily itraconazole and in 65 of 72 fluconazole-treated patients (90%) at the end of treatment; these results were statistically equivalent (P = .0024). Twice-daily itraconazole produced a clinical response in 51 of 62 patients (82%). The groups were equivalent in terms of early relapse (within the 18-day period studied); 37% of patients in the twice-daily itraconazole group, 35% in the once-daily itraconazole group, and 34% in the fluconazole group relapsed. Drug tolerability was comparable between the three groups. These results show that, in the treatment of oropharyngeal candidiasis, itraconazole oral solution and fluconazole capsules at a 100-mg single daily dose for 14 days are equally effective.