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The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Acyclovir

Medicamento
Quiénes están siendo reclutados

Herpes Simplex

+ HIV Infections
A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 31 de octubre de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Part A: To evaluate the impact of HSV suppression with acyclovir ( ACV ) on HIV burden in patients with asymptomatic HSV infection and at high risk for HSV reactivation. Part B: To characterize the change in plasma HIV RNA levels and other measures of HIV burden during and after a 10 day course of ACV treatment for acute HSV infection. Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA. There is a need to determine the patterns of association between HSV and HIV. Approximately 70% of patients infected with HIV are concurrently infected with HSV. There is new evidence to suggest that HSV may act as a co-factor in HIV disease progression. This study will attempt to determine if the upregulation of HIV RNA that occurs during symptomatic HSV reactivation also occurs during asymptomatic HSV reactivation and if suppression of HSV will result in decreased levels of HIV RNA. There is a need to determine the patterns of association between HSV and HIV. Part A: 60 approved HIV infected patients will be randomized to either suppressive ACV therapy or matching placebo for 12 weeks. Serology for HSV serum antibodies will be obtained at screening and a full history and physical exam will be performed on Day 1 and interval examinations at Weeks 2, 4, 8 and 12. Extensive clinical exams will be conducted on a regular schedule throughout the 12 weeks. Part B: 15 approved HIV infected patients will receive treatment with ACV until resolution of the lesion. All patients will be monitored on Day 9-12 of ACV therapy for crusting and resolutions of HSV lesions and will be followed for 3.5 months. AS PER AMENDMENT 3/11/97: Noncommercial active acyclovir will be made available for Part A patients wo develop acute HSV while on study and for Part B patients who develop acute HSV after completion of the acute phase of treatment ( i.e., during the follow-up phase).

Título OficialA Pilot Study to Determine the Effect of Acyclovir Treatment for Herpes Simplex Virus (HSV) Infection on Peripheral Blood HIV Viral Load. 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 31 de octubre de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 75 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Ni los participantes ni los investigadores saben quién está recibiendo qué tratamiento. Esta es la forma más rigurosa de reducir el sesgo, asegurando que las expectativas no influyan en los resultados.

Otras formas de enmascarar la información
Abierto
: Todos saben qué tratamiento se está administrando.

Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 13 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Herpes Simplex
HIV Infections
Criterios

Inclusion Criteria Patients must have: Parts A and B: * Documented HIV infection. * Patients \>= 18 years of age must be willing and able to give informed consent and patients \< 18 years must have written consent from a parent or guardian. Part A: * CD4+ T count \< 250 cells/mm3 within 1 month prior to study entry. * Documented antibodies to HSV any time prior to study. * History of HSV outbreak in past 2 to 12 months. * Former Part B patients who have completed the 12 week follow up may enter Part A after at least a 4-week washout. Part B: * Documented CD4+ T count \< 250 cells/mm3 anytime prior to study entry. * Oral, genital or anorectal lesions with a vesiculopustular component. * Presumptive diagnosis of HSV. * Former part A patients may enter part B after a 4-week washout. Exclusion Criteria Patients with any of the following prior conditions are excluded: * Documented or suspected HSV within 2 months prior to study entry. * History of infection with an acyclovir resistant HSV strain. * History of disseminated HSV. * History of treatment for acute CMV or MAC disease. * History of poor medication or clinic visit compliance. Prior Medication: Excluded: * Use of acyclovir, famciclovir, foscarnet, ganciclovir, valacyclovir or cidofovir for any reason within one month prior to study entry. \[AS PER AMENDMENT 1/21/97: Use of antiherpes agents, both FDA-approved and investigational, including bis-POM, PMEA, lobucavir, acyclovir, etc.\] * Initiation or modification of antiretroviral therapy, immunomodulators, or any kind of vaccination within 2 months prior to study entry. * Treatment for acute medical condition within 4 weeks prior to study entry.



Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene 15 ubicaciones
Suspendido
AIDS Research CtrPalo Alto, United StatesVer ubicación
Suspendido
Harbor-UCLA Med CtrTorrance, United States
Suspendido
Yale Univ School of Medicine / AIDS ProgramNew Haven, United States
Suspendido
North Broward Hosp DistrictFort Lauderdale, United States

Completado15 Centros de Estudio