학술논문
Randomized, Comparative, Double-Blind, Double-Dummy, Multicenter Trial of Miconazole Buccal Tablet and Clotrimazole Troches for the Treatment of Oropharyngeal Candidiasis: Study of Miconazole Lauriad® Efficacy and Safety (SMiLES)
Document Type
Academic Journal
Author
Source
HIV Clinical Trials. Jul 01, 2010 11(4):186-196
Subject
Language
English
ISSN
1528-4336
Abstract
BACKGROUND:: Oropharyngeal candidiasis (OPC) is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Once-daily miconazole 50 mg buccal tablet (MBT) is a novel delivery system using an extendedspectrum azole with potent in vitro activity against many Candida species, including some that may be resistant to other azoles. METHODS:: This phase 3, double-blind, double-dummy, multicenter trial evaluated 578 randomized patients with HIV infection and OPC. The study compared the efficacy and safety of MBT once daily with clotrimazole 10 mg troches (CT) 5 times daily for 14 days. The co-primary efficacy endpoints were clinical cure at test of cure (TOC) visit (days 17–22) in the intent-to-treat (ITT) and per protocol (PP) populations. RESULTS:: Clinical cure rate at TOC visit for MBT-treated patients was statistically noninferior to CT-treated patients in both the ITT (61% vs 65%) and PP (68% vs 74%) populations. Secondary endpoints, safety, and tolerability were similar between treatment groups. CONCLUSIONS:: In this large trial, once-daily MBT was shown to be noninferior to CT 5 times daily in the treatment of OPC in HIV- positive patients. MBT offers an effective, safe, and well-tolerated topical treatment option for OPC administered as a convenient once-daily dose.