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).
Author(s): Vazquez JA, Patton LL, Epstein JB, Ramlachan P, Mitha I, Noveljic Z, Fourie J,
Conway B, Lalla RV, Barasch A, Attali P; SMiLES Study Group.
Collaborators: Conway B, Kilby D, LaLonde R, Tsoukas C, Noveljic Z, Ramlachan P,
Mitha I, Fourie J, Malan D, Kelfkens Y, Engelbrecht J, Andrews S, Van Vuuren J,
Petit D, Vazquez J, Lalla R, Barasch A, La Marca A, Meiller T, Osiyemi O, Kutcher
M, Nichols CM, Sroussi H, Muzyka B, Beal J, Borkert C, Patel S, Ernst J, Bolan R,
Bartczak J, Patton L, Epstein J, Sobel J, Perfect J, Thorn M, Frederick S, Lucas
G.
Affiliation(s): Division of Infectious Diseases, Henry Ford Hospital, Detroit, Michigan 48201,
USA. jvazque1@hfhs.org
Publication date & source: 2010, HIV Clin Trials. , 11(4):186-96
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.
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