Clinical Trial: Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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) In
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.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: Percent of patients that have a clinical response assessed by symptoms and physical examination [ Time Frame: Day 21 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: 7 days after end of treatment ]
- Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: after 14 days of treatment ]
- Clinical response by symptom assessment and physical examination [ Time Frame: after 7 and 14 days of treatment ]
- Assessment of compliance with Treatment by troche Count and Patient interview [ Time Frame: after 7 and 14 days of treatment ]
Original Secondary Outcome: Same as current
Information By: Boehringer Ingelheim
Dates:
Date Received: July 8, 2014
Date Started: May 2001
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014
