Effect of Boceprevir on HCV-specific T Cell Responses (Boce-Par)
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|ClinicalTrials.gov Identifier: NCT01403181|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : November 6, 2013
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis C||Drug: Boceprevir|
Reconstitution of the antiviral T cell function may represent a component of the anti-viral effect of protease inhibitors. If T cell responsiveness is restored under therapy, potentiation of anti-viral T cell functions by exogenous T cell stimulation might be exploited to complement and to further improve response to available therapies. Monitoring the T cell function might also be useful to predict more accurately response to therapy.
To address these issues, phenotype and function of HCV-specific T cells will be analyzed longitudinally before, during and after therapy in naïve genotype 1 chronic hepatitis C patients treated with peginterferon plus ribavirin or with peginterferon and ribavirin plus boceprevir. To analyze the global CD4 and CD8 reactivity against all structural and non-structural HCV proteins a wide panel of peptides corresponding to the whole HCV genome of genotype 1 will be employed. To further analyze CD8 reactivity, HLA-A2/peptide tetramers will be used in HLA-A2 positive patients to directly quantify ex vivo HCV-specific CD8 cells circulating in the peripheral blood.The T cell function will be analyzed as capacity of expansion in vitro, cytokine production and cytotoxicity.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Effect of Boceprevir Therapy on HCV-specific T Cell Responses: Perspectives of Immune Monitoring and Immune Therapy|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2013|
Chronic hepatitis C
In the experimental arm boceprevir (800 mg orally three times daily), PEG-IFN and ribavirin will be given for 24 weeks after the lead-in; the patients who will have undetectable HCV-RNA at week 8 will stop treatment at week 28; those who will be HCV-RNA positive at any visit between week 8 and 24 will receive an additional 20 weeks of PEG + RBV. Treatment will be discontinued if HCV-RNA is positive at week 24.
Immunological analysis will be performed longitudinally at the following time points: week -4, 0, 4 (end of lead-in), 8, 12, 24, 48, week 24 of follow-up. HCV-RNA will be quantified at the same time points and viremia will be correlated with immunological data.
Other Name: Peginterferon alfa-2b and ribavirin
- Levels of HCV-specific T cell functions before, during and after therapy to measure functional restoration induced by therapy [ Time Frame: 2 years ]Capacity of expansion, cytokine production (IFN-γ, IL-2 and TNF-α) and cytotoxicity expressed by HCV-specific T cells will be analyzed longitudinally at different time points before, during and after therapy
- Correlation of quality and intensity of pre-treatment HCV-specific T cell responses with outcome of therapy [ Time Frame: 2 years ]To assess whether different levels of efficiency of pre-treatment antiviral T cell responses can predict response to treatment.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403181
|Unit of Infectious Diseases and Hepatology|
|Parma, Italy, 43126|
|Principal Investigator:||Carlo Ferrari, MD||Azienda Ospedaliero-Universitaria di Parma|