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

Phase 3

Completed

• Conditions: Candidiasis, Oral
• Interventions: Drug: Mycelex® troches; Drug: Roxanes's clotrimazole troches

• Registration Number: NCT02184351
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2001-11
• Status Verified: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycelex® troches	Mycelex® troches	-
Roxanes's clotrimazole troches	Roxanes's clotrimazole troches	-

Primary Outcome Measures

Name	Time	Method
Percent of patients that have a clinical response assessed by symptoms and physical examination	Day 21

Secondary Outcome Measures

Name	Time	Method
Incidence of negative fungal cultures of the oropharynx for Candida species	after 14 days of treatment
Clinical response by symptom assessment and physical examination	after 7 and 14 days of treatment
Assessment of compliance with Treatment by troche Count and Patient interview	after 7 and 14 days of treatment