FDA 236B.

Trial name or title	An open study of the effect of itraconazole oral solution for the treatment of fluconazole refractory oropharyngeal candidiasis in HIV‐positive subjects
Methods	Patients receive itraconazole oral solution twice daily. Complete resolution of OC lesions on completion of treatment ‐ eligible for maintenance ‐ Decline maintenance are followed for six weeks. Relapse during follow‐up are retreated for 14 ‐ 28 days. If lesions clear, enter maintenance. Open label study.
Participants	Inclusion criteria: 1 to 65 yrs old; HIV antibody seropositivity or diagnosis of AIDS; Confirmed OC; Failed fluconazole treatment with past 14 days; Life expectancy of at least 3 months; NO symptoms of esophageal candidiasis; No prior disseminate candidiasis
Interventions
Outcomes	Endpoint classification: Safety study Primary purpose: Treatment
Starting date	Not provided
Contact information	Not provided
Notes	No publications provided. Study completed. Clincal Trials.gov: NCT00002133