Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Candidiasis, Oral

Treatments

Drug: Roxanes's clotrimazole troches

Drug: Mycelex® troches

Study type

Interventional

Funder types

Industry

Identifiers

NCT02184351

1190.1

Details and patient eligibility

About

The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.

Enrollment

187 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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