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)
Vazquez, Jé.A.; Patton, L.L.; Epstein, J.B.; Ramlachan, P.; Mitha, I.; Noveljic, Z.; Fourie, J.; Conway, B.; Lalla, R.V.; Barasch, A.; Attali, P.; 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.; L.M.rca, A.; Meiller, T.; Osiyemi, O.; Kutcher, M.; Nichols, C.M.; Sroussi, H.; Muzyka, B.; Beal, J.; Borkert, C.; Patel, S.; Ernst,
HIV Clinical Trials 11(4): 186-196
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. 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. 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. 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.