DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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.

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017