Back to resultsClotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Primary Purpose
Candidiasis, Oral
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Roxanes's clotrimazole troches
Mycelex® troches
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Oral
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Roxanes's clotrimazole troches
Mycelex® troches
Arm Description
Outcomes
Primary Outcome Measures
Percent of patients that have a clinical response assessed by symptoms and physical examination
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184351
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
November 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roxanes's clotrimazole troches
Arm Type
Experimental
Arm Title
Mycelex® troches
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Roxanes's clotrimazole troches
Intervention Type
Drug
Intervention Name(s)
Mycelex® troches
Primary Outcome Measure Information:
Title
Percent of patients that have a clinical response assessed by symptoms and physical examination
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Incidence of negative fungal cultures of the oropharynx for Candida species
Time Frame
7 days after end of treatment
Title
Incidence of negative fungal cultures of the oropharynx for Candida species
Time Frame
after 14 days of treatment
Title
Clinical response by symptom assessment and physical examination
Time Frame
after 7 and 14 days of treatment
Title
Assessment of compliance with Treatment by troche Count and Patient interview
Time Frame
after 7 and 14 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1190/1190.1_U02-3190.pdf
Description
Related Info
Learn more about this trial
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
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