Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02184351
Eligibility Criteria:
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, with culture 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 and agreement to use adequate contraception (investigator's discretion) while on study drug
* Mental status allows comprehension of instructions for troche administration
* Written informed consent
Exclusion Criteria:
* Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
* 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 the study (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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02184351
Study Brief:
Protocol Section:
NCT02184351