This open-label, multicenter trial evaluated the efficacy and safety of a new oral solution formulation of itraconazole in HIV+/AIDS patients with fluconazole-refractory oropharyngeal candidiasis. Seventy-four HIV+/AIDS patients with mycologically confirmed oropharyngeal candidiasis who failed fluconazole therapy (200 mg/day) were treated with 100 mg of itraconazole oral solution administered twice daily (200 mg/day) for 14 days. Patients who demonstrated an incomplete response to treatment were treated for an additional 14 days (28 days total). Clinical responders were eligible for participation in a separate 6-month maintenance protocol. If they declined further treatment, responders were monitored for 6 weeks posttreatment. The primary efficacy parameter was clinical response (i.e., no lesions or symptoms) at end of treatment. Fungal cultures were performed at baseline and at the end of treatment. Among the 74 patients who mycologically confirmed, fluconazole-unresponsive, oropharyngeal candidiasis at baseline, 41 (55%) achieved a clinical response by day 28. The median time to response was 7 days (range, 7 to 28 days). Candida albicans was the most common pathogen isolated, either alone (62%) or in combination with another Candida species (31%). All 22 patients who entered the optional, off-therapy, 6-week follow- up phase relapsed; mean time to relapse was 13 days. Itraconazole oral solution was well-tolerated; adverse events were predominantly gastrointestinal disturbances. This trial demonstrates that itraconazole oral solution is a useful therapy in the treatment of HIV-infected patients with fluconazole-refractory oropharyngeal candidiasis.
