RESUMEN
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.
Asunto(s)
Infecciones Oportunistas Relacionadas con el SIDA/tratamiento farmacológico , Antifúngicos/administración & dosificación , Candidiasis Bucal/tratamiento farmacológico , Clotrimazol/administración & dosificación , Infecciones por VIH/microbiología , Miconazol/administración & dosificación , Infecciones Oportunistas Relacionadas con el SIDA/microbiología , Administración Bucal , Administración Oral , Adulto , Antifúngicos/efectos adversos , Antifúngicos/sangre , Candida/crecimiento & desarrollo , Candidiasis Bucal/virología , Distribución de Chi-Cuadrado , Clotrimazol/efectos adversos , Método Doble Ciego , Femenino , VIH/crecimiento & desarrollo , Infecciones por VIH/inmunología , Infecciones por VIH/virología , Humanos , Masculino , Miconazol/efectos adversos , Miconazol/sangre , Cooperación del PacienteRESUMEN
Twenty-five AIDS patients were treated with HE2000, a synthetic adrenal hormone. The drug was well tolerated and safe and reduced both the incidence of tuberculosis coinfection by 42.2% (P < 0.05) and the cumulative incidence of opportunistic infections (P < 0.05). These results warrant further clinical investigation of HE2000.