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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 species

Incidence 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

Page last updated: August 23, 2015

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