Status:
COMPLETED
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Candidiasis, Oral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT02184351
Start Date
May 1 2001
Last Update
July 14 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.