Clinical trial NCT02184351: Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Oral
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of patients that have a clinical response assessed by symptoms and physical examination
timeFrame: Day 21
Secondary outcomes:
measure: Incidence of negative fungal cultures of the oropharynx for Candida species
timeFrame: 7 days after end of treatment
measure: Incidence of negative fungal cultures of the oropharynx for Candida species
timeFrame: after 14 days of treatment
measure: Clinical response by symptom assessment and physical examination
timeFrame: after 7 and 14 days of treatment
measure: Assessment of compliance with Treatment by troche Count and Patient interview
timeFrame: after 7 and 14 days of treatment
Other outcomes:
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