Terminé

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

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Ce qui est collecté

Collecte de données

Qui peut participer

Infections transmises par le sang
+11

+ Maladies Transmissibles
+ Maladies du système digestif
À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Observationnel
Date de début : janvier 2004
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude
Date de début de l'étude : 14 janvier 2004Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielEvaluation of Clinical, Virologic and Immunologic Factors That Contribute to the Pathogenesis of Chronic Hepatitis C and Its Complications 
NCT00076427
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 14 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
327 participants à inclureNombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
Infections transmises par le sang
Maladies Transmissibles
Maladies du système digestif
Infections à entérovirus
Hépatite
Hépatite A
Hépatite C
Hépatite virale humaine
Infections
Maladies du foie
Infections à Picornaviridae
Infections à virus ARN
Maladies virales
Infections à Flaviviridae
Critères

* 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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 4 sites
Suspendu
Family and Medical Counseling ServiceWashington, D.C., United StatesVoir le site
Suspendu
Unity Health Care/Walker JonesWashington, D.C., United States
Suspendu
Whitman Walker ClinicWashington, D.C., United States
Suspendu
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United States
Terminé4 Centres d'Étude