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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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)
HIV Clinical Trials, Volume 11, No. 4, Year 2010
Notification
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Description
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 extended-spectrum 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. © 2010 Thomas Land Publishers, Inc.
Authors & Co-Authors
Vázquez, José A.
United States, Detroit
Henry Ford Health System Division of Infectious Diseases
United States, Detroit
Wayne State University
Patton, Lauren L.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Epstein, Joel Brian
United States, Chicago
University of Illinois at Chicago
Ramlachan, P.
South Africa, Durban
Durban Section
Mitha, Ismail Haroon
South Africa
Benoni, sa
Noveljic, Zoja
South Africa, Bellville
Karl Bremer Hospital
Fourie, Jan
Unknown Affiliation
Conway, Brian
Canada, Vancouver
The University of British Columbia
Lalla, Rajesh
United States, Farmington
Uconn Health
Barasch, Andrei
United States, Birmingham
The University of Alabama at Birmingham
Attali, Pierre
France, Paris
Onxeo S.a.
France, Le Kremlin-bicetre
Hopital de Bicetre
Statistics
Citations: 43
Authors: 11
Affiliations: 12
Identifiers
Doi:
10.1310/hct1104-186
ISSN:
15284336
Research Areas
Disability
Infectious Diseases