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

NCT ID: NCT02184351

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31

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.

Conditions

Candidiasis, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Roxanes's clotrimazole troches

Group Type: EXPERIMENTAL

Roxanes's clotrimazole troches

Intervention Type: DRUG

Mycelex® troches

Group Type: ACTIVE_COMPARATOR

Mycelex® troches

Intervention Type: DRUG

Interventions

Roxanes's clotrimazole troches

Intervention Type: DRUG

Mycelex® troches

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1190.1

Identifier Type: -

Identifier Source: org_study_id