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

Candidiasis, Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184351
• Other study ID #: 1190.1
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2014
• Last updated: July 11, 2014
• Start date: May 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral

Intervention

Drug:
• Roxanes's clotrimazole troches

• Mycelex® troches

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients that have a clinical response assessed by symptoms and physical examination		Day 21	No
Secondary	Incidence of negative fungal cultures of the oropharynx for Candida species		7 days after end of treatment	No
Secondary	Incidence of negative fungal cultures of the oropharynx for Candida species		after 14 days of treatment	No
Secondary	Clinical response by symptom assessment and physical examination		after 7 and 14 days of treatment	No
Secondary	Assessment of compliance with Treatment by troche Count and Patient interview		after 7 and 14 days of treatment	No

External Links

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