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Evaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications

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Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Enfermedades Transmisibles
+10

+ Infecciones Transmitidas por la Sangre
+ Enfermedades del Sistema Digestivo
A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Observacional
Inicio del estudio: enero de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 14 de enero de 2004Fecha en la que se inscribió al primer participante.

Hepatitis C virus (HCV) and Hepatitis B (HBV) infection are known to cause morbidity and mortality especially among those who are coinfected with Human Immunodeficiency virus (HIV). HCV infected individuals who are also coinfected with HIV have more rapid progression of liver disease, abnormal diagnostic serologies, higher levels of HCV viremia, and markedly lower levels of therapeutic responses to the standard combination therapy with peginterferon and ribavirin. The underlying immunopathogenesis of HCV and HBV infection, progression of liver disease, and interactions with HIV are not yet clearly understood. A clear understanding of the immune correlates of protection against HCV and HBV are important in development of a vaccine for HCV and novel immune-based therapeutics for the cure of HBV. This study will recruit individuals who are coinfected with HIV and HCV and/or HBV as well as those who are monoinfected with HCV or HBV. The study will enroll 2 groups. Participants in the first group (hereafter referred to as Group 1) will consist of participants recruited for research and clinical related blood draws, leukapheresis, and liver biopsies for long term study participation. Participants in the second group (hereafter referred to as Group 2) will consist of participants with known or suspected HCV and/or HBV who need assistance with diagnosis or treatment. Participants in Group 1 will be apheresed or undergo blood draw several times after enrollment and may be followed for up to 10 years. Participants in Group 2 will be evaluated for HBV and/or HCV infection or complications, or receive treatment. The expectation is that may be followed for one year. Leukapheresis is used in Group 1 in order to obtain sufficient cells to pursue the following objectives: delineating B cell response to CD4+ T cell help, delineating CD8+ T factors associated with suppression of viral replication and normalization of immune function, characterizing natural killer function relative to HCV and/or HBV disease, and identifying biomarkers for progression of liver disease. The required number of mononuclear cells needed to perform these experiments can be easily and safely obtained using leukapheresis procedures in the Clinical Center Apheresis Unit. Participants who do not meet apheresis criteria may participate through routine blood draws to contribute to this research. All participants in Group 1 may also receive a liver biopsy at NIH (every 3 years for HIV/HCV coinfected and all HBV infected and every 5 years for HCV monoinfected subjects) to assess the progression of liver disease. Treatment plans for Group 2 HBV and/or HCV will be in accordance with standard medical practice, and the number and length of additional visits and diagnostic evaluations will vary accordingly.

Título OficialEvaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications 
NCT00076427
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 14 de enero de 2026
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 327 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.

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 18 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
Enfermedades Transmisibles
Infecciones Transmitidas por la Sangre
Enfermedades del Sistema Digestivo
Infecciones por enterovirus
Hepatitis
Hepatitis C
Hepatitis viral humana
Hepatitis A
Infecciones
Enfermedades del Hígado
Infecciones por Picornaviridae
Infecciones por virus de ARN
Enfermedades Virales
Criterios

* INCLUSION CRITERIA FOR BOTH GROUPS: * Adult (18 years old or older) * Either monoinfected with HCV or coinfected with HCV and HIV * Willingness to give informed consent. * Willing to undergo genetic testing * Willing to have samples stored for future research. * Must have a referring physician or clinic that will continue to provide medical care. Note: An HCV/HIV coinfected individual is defined as any individual with all the following: 1) Positive ELISA and western blot test for HIV, and 2) Positive serology and/or positive HCV RNA test; An HCV monoinfected individual is defined as any individual with all of the following: 1) Positive serology and/or positive HCV RNA test, and 2) Negative ELISA test for HIV INCLUSION CRITERIA FOR GROUP 1: -Must be willing and able to make follow up visits for leukapheresis and blood draws at least once in the next 6 months INCLUSION CRITERIA FOR GROUP 2: -Must be referred by a physician for the purposes of confirming HCV diagnosis, complications from HCV, or standard HCV treatment management. EXCLUSION CRITERIA FOR BOTH GROUPS Have any other condition, which the investigator considers a contraindication to study participation. EXCLUSION FOR GROUP 1: * Evidence of liver failure on liver biopsy, abdominal ultrasound, or liver function blood tests * Receiving HCV therapy at the time of enrollment * Platelet count \< 50,00 per mL * Hematocrit \< 28 percent.

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 4 ubicaciones
Suspendido
Family and Medical Counseling ServiceWashington, D.C., United StatesVer ubicación
Suspendido
Unity Health Care/Walker JonesWashington, D.C., United States
Suspendido
Whitman Walker ClinicWashington, D.C., United States
Suspendido
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United States
Completado4 Centros de Estudio