Safety and efficacy of single-dose fluconazole compared with a 7-day regimen of itraconazole in the treatment of AIDS-related oropharyngeal candidiasis.

The primary aim of this study was to compare the efficacy and safety of single-dose fluconazole and a 7-day regimen of itraconazole for the treatment of oropharyngeal candidiasis in human immunodeficiency virus (HIV)-positive patients. In this open-label trial, 40 HIV-positive patients with oropharyngeal candidiasis were randomized to receive either one dose of fluconazole 150 mg or seven daily doses of itraconazole 100 mg. Clinical condition was assessed at baseline, day 8, and day 30 (follow-up). In the fluconazole group, 15 of 20 (75%) patients were clinically cured on day 8, three (15%) were clinically improved, and two (10%) were treatment failures. At follow-up, six (30%) patients experienced relapse. In the itraconazole group, four of 17 (24%) patients were clinically cured at 8 days, and two (12%) were clinically improved; two patients relapsed by day 30. Ten (50%) patients in the itraconazole group were taking concomitant medications that could potentially affect the bioavailability of itraconazole. After excluding the results from these patients, clinical response rates remained significantly higher in the fluconazole treatment arm. These results suggest that a single 150-mg dose of fluconazole may be a safe, effective, and convenient therapy for acquired immune deficiency syndrome-related oropharyngeal candidiasis. The lower response rate in the patients who received itraconazole 100 mg daily for 7 days could be explained by drug interactions and the unpredictable absorption of itraconazole.