Treatment of fluconazole-refractory oropharyngeal candidiasis with itraconazole oral solution in HIV-positive patients

This open-label, multicenter trial evaluated the efficacy and safety of a n ew oral solution formulation of itraconazole in HIV+/AIDS patients with flu conazole-refractory oropharyngeal candidiasis. Seventy-four HIV+/AIDS patie nts with mycologically confirmed oropharyngeal candidiasis who failed fluco nazole therapy (200 mg/day) were treated with 100 mg of itraconazole oral s olution administered twice daily (200 mg/day) for 14 days. Patients who dem onstrated an incomplete response to treatment were treated for an additiona l 14 days (28 days total), Clinical responders were eligible for participat ion in a separate 6-month maintenance protocol. If they declined further tr eatment, responders were monitored for 6 weeks posttreatment. The primary e fficacy parameter was clinical response (i.e,, no lesions or symptoms) at e nd of treatment, Fungal cultures were performed at baseline and at the end of treatment, Among the 74 patients who had mycologically confirmed, flucon azole-unresponsive, oropharyngeal candidiasis at baseline, 41 (55%) achieve d a clinical response by day 28, The median time to response was 7 days (ra nge, 7 to 28 days). Candida albicans was the most common pathogen isolated, either alone (62%) or in combination with another Candida species (31%), A ll 22 patients who entered the optional, off-therapy, 6-week follow-up phas e relapsed; mean time to relapse was 13 days. Itraconazole oral solution wa s well-tolerated; adverse events were predominantly gastrointestinal distur bances. This trial demonstrates that itraconazole oral solution is a useful therapy in the treatment of HIV-infected patients with fluconazole-refract ory oropharyngeal candidiasis.