Phase
Condition
Systemic Fungal Infections
Fungal Infections
Sexually Transmitted Diseases (Stds)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented HIV positive status
Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear)consistent with Candida species or positive fungal culture for Candida species, withculture obtained in the 2 days preceding initiation of therapy with the study drug
Male or female patients ≥ 18 years
For women of childbearing potential: negative blood or urine pregnancy test andagreement to use adequate contraception (investigator's discretion) while on studydrug
Mental status allows comprehension of instructions for troche administration
Written informed consent
Exclusion
Exclusion Criteria:
Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia orodynophagia) unless the results of an endoscopic evaluation of the esophagus arenegative
Presence of perioral lesions only
Use of other antifungal agents within 5 days of enrollment to the study
Pregnant or lactating women
History of hypersensitivity to imidazole or azole compounds
Patient unwilling or unable to be followed at the study center for the duration of thestudy (3 weeks)
Patients has received an investigational drug in the last 30 days
Treatment with another investigational drug is planned within the next 3 weeks