FDA 288A.

Trial name or title	A multicenter, randomised, double‐blind, phase II study to evaluate the safety, tolerance and efficacy of multiple doses of SCH 56591 versus fluconazole in the treatment of oropharyngeal candidiasis (OPC) in HIV‐positive patients
Methods	Randomized, double‐blind, multi‐center study consisting of five arms
Participants	Inclusion criteria: 18 to 65 yrs old; Documented HIV seropositivity; Pseudomembranous OC; Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture; Ability to swallow medicine Estimated enrolment: 500
Interventions	4 dose levels of SCH 56592 vs fluconazole
Outcomes	Endpoint classification: Safety study Primary purpose: Treatment
Starting date	Not available
Contact information
Notes	Study completed. No publications found. Clincal Trials.gov: NCT00002399