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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, José A; Patton, Lauren L; Epstein, Joel B; Ramlachan, Padaruth; Mitha, Ismail; Noveljic, Zoja; Fourie, Jan; Conway, Brian; Lalla, Rajesh V; Barasch, Andrei; Attali, Pierre.
Afiliação
  • Vazquez JA; Division of Infectious Diseases, Henry Ford Hospital, Detroit, Michigan 48201, USA. jvazque1@hfhs.org
HIV Clin Trials ; 11(4): 186-96, 2010.
Article em En | MEDLINE | ID: mdl-20974574
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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Candidíase Bucal / Infecções por HIV / Clotrimazol / Infecções Oportunistas Relacionadas com a AIDS / Miconazol / Antifúngicos Tipo de estudo: Clinical_trials / Guideline Limite: Adult / Female / Humans / Male Idioma: En Revista: HIV Clin Trials Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) / TERAPEUTICA Ano de publicação: 2010 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Candidíase Bucal / Infecções por HIV / Clotrimazol / Infecções Oportunistas Relacionadas com a AIDS / Miconazol / Antifúngicos Tipo de estudo: Clinical_trials / Guideline Limite: Adult / Female / Humans / Male Idioma: En Revista: HIV Clin Trials Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) / TERAPEUTICA Ano de publicação: 2010 Tipo de documento: Article País de afiliação: Estados Unidos