Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral
Intervention: Roxanes's clotrimazole troches (Drug); Mycelex® troches (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: Percent of patients that have a clinical response assessed by symptoms and physical examination
Secondary outcome: Incidence of negative fungal cultures of the oropharynx for Candida speciesIncidence of negative fungal cultures of the oropharynx for Candida species Clinical response by symptom assessment and physical examination Assessment of compliance with Treatment by troche Count and Patient interview
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2001
Last updated: July 11, 2014
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