VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
2 de agosto de 2017 actualizado por: GlaxoSmithKline
Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
73
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Carmichael, California, Estados Unidos, 95608
- GSK Investigational Site
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Davis, California, Estados Unidos, 95616
- GSK Investigational Site
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Riverside, California, Estados Unidos, 92506
- GSK Investigational Site
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Sacramento, California, Estados Unidos, 92585
- GSK Investigational Site
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- GSK Investigational Site
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Indianapolis, Indiana, Estados Unidos, 46202
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- GSK Investigational Site
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New York
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New York, New York, Estados Unidos, 10029
- GSK Investigational Site
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New York, New York, Estados Unidos, 10011
- GSK Investigational Site
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Stony Brook, New York, Estados Unidos, 11794
- GSK Investigational Site
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The Bronx, New York, Estados Unidos, 10461
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
- GSK Investigational Site
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- GSK Investigational Site
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Texas
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Houston, Texas, Estados Unidos, 77030
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- GSK Investigational Site
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Washington
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Seattle, Washington, Estados Unidos, 98104
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- In overall general good health.
- HSV-2 (Herpes Simplex Virus-2) seropositive at screening.
Exclusion criteria:
- have active lesions consistent with genital herpes.
- previous history of symptomatic genital herpes.
- history of recurrent, undiagnosed symptoms consistent with genital herpes.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
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placebo
Valtrex 1g once daily
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Experimental: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
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placebo
Valtrex 1g once daily
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
|
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100.
For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions).
Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
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Up to Day 60 of each treatment period (up to 160 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Percent Days of Total HSV-2 Shedding
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
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The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected.
Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group.
For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR.
Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
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Up to Day 60 of each treatment period (up to 160 days)
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Number of Participants With no Shedding
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
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The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data.
During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR.
During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR.
For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
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Up to Day 60 of each treatment period (up to 160 days)
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Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
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The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR.
Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days.
During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR.
During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR.
For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
|
Up to Day 60 of each treatment period (up to 160 days)
|
|
Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
|
The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR.
Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days.
During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR.
During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR.
For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
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Up to Day 60 of each treatment period (up to 160 days)
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Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
Periodo de tiempo: Up to Day 60 of each treatment period (up to 160 days)
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Participants who have recognized clinical signs/symptoms of genital herpes infection during the study.
Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit.
Genital examinations was conducted at the randomization and genital herpes outbreak visits.
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Up to Day 60 of each treatment period (up to 160 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de marzo de 2005
Finalización primaria (Actual)
10 de enero de 2006
Finalización del estudio (Actual)
10 de enero de 2006
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2005
Primero enviado que cumplió con los criterios de control de calidad
30 de junio de 2005
Publicado por primera vez (Estimar)
1 de julio de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
2 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VLX103596
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Especificación del conjunto de datos
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: VLX103596Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .