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)

Jose Antonio Vazquez, Lauren Patton, Joel Epstein, Padaruth Ramlachan, Ismail Mitha, Zoja Noveljic, Jan Fourie, Brian Conway, Rajesh Lalla, Andrei Barasch, Pierre Attali

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)186-196
Number of pages11
JournalHIV Clinical Trials
Volume11
Issue number4
DOIs
StatePublished - Jan 1 2010

Fingerprint

Clotrimazole
Miconazole
Cheek
Candidiasis
Tablets
Multicenter Studies
Safety
Azoles
HIV
Therapeutics
Opportunistic Infections
Virus Diseases
Candida
Population

Keywords

  • HIV-related opportunistic infections
  • antifungal agents
  • clotrimazole
  • miconazole
  • oral candidiasis

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

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, Jose Antonio; Patton, Lauren; Epstein, Joel; Ramlachan, Padaruth; Mitha, Ismail; Noveljic, Zoja; Fourie, Jan; Conway, Brian; Lalla, Rajesh; Barasch, Andrei; Attali, Pierre.

In: HIV Clinical Trials, Vol. 11, No. 4, 01.01.2010, p. 186-196.

Research output: Contribution to journalArticle

Vazquez, Jose Antonio ; Patton, Lauren ; Epstein, Joel ; Ramlachan, Padaruth ; Mitha, Ismail ; Noveljic, Zoja ; Fourie, Jan ; Conway, Brian ; Lalla, Rajesh ; Barasch, Andrei ; Attali, Pierre. / 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). In: HIV Clinical Trials. 2010 ; Vol. 11, No. 4. pp. 186-196.
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AU - Vazquez, Jose Antonio

AU - Patton, Lauren

AU - Epstein, Joel

AU - Ramlachan, Padaruth

AU - Mitha, Ismail

AU - Noveljic, Zoja

AU - Fourie, Jan

AU - Conway, Brian

AU - Lalla, Rajesh

AU - Barasch, Andrei

AU - Attali, Pierre

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AB - 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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