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).
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.
Division of Infectious Diseases, Henry Ford Hospital, Detroit, Michigan 48201, USA. jvazque1@hfhs.org
José A
JA
Vazquez
Lauren L
LL
Patton
Joel B
JB
Epstein
Padaruth
P
Ramlachan
Ismail
I
Mitha
Zoja
Z
Noveljic
Jan
J
Fourie
Brian
B
Conway
Rajesh V
RV
Lalla
Andrei
A
Barasch
Pierre
P
Attali
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000278:Administration, Buccal; D000284:Administration, Oral; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D002175:Candida / Q000254:growth & development; D002180:Candidiasis, Oral / Q000188:drug therapy* / Q000821:virology; D016009:Chi-Square Distribution; D003022:Clotrimazole / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006678:HIV / Q000254:growth & development; D015658:HIV Infections / Q000276:immunology / Q000382:microbiology* / Q000821:virology; D006801:Humans; D008297:Male; D008825:Miconazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D010349:Patient Compliance
D000935:Antifungal Agents; D008825:Miconazole; D003022:Clotrimazole