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

A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

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.

Study Overview

• Status: Completed
• Conditions: Candidiasis, Oral
• Intervention / Treatment: Drug: Roxanes's clotrimazole troches; Drug: Mycelex® troches

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Roxanes's clotrimazole troches	Drug: Roxanes's clotrimazole troches
Active Comparator: Mycelex® troches	Drug: Mycelex® troches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of patients that have a clinical response assessed by symptoms and physical examination	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of negative fungal cultures of the oropharynx for Candida species	7 days after end of treatment
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): November 1, 2001

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Candidiasis, Oral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: 1190.1