Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4. The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Erasmus MC
Rotterdam, South Holland, Netherlands
AMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Slotervaart
Amsterdam, Netherlands
Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.
The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.
Time frame: 12 weeks
SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).
The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy
Time frame: 12 weeks
SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.
The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment
Time frame: 12 weeks
SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.
The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.
Time frame: 12 weeks
Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.
Time frame: 72 weeks
Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.
only serious adverse events are recorded in this secondary endpoint
Time frame: 72 weeks
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Ziekenhuis Rijnstate
Arnhem, Netherlands
UMCG
Groningen, Netherlands
MUMC
Maastricht, Netherlands
Radboud UMCN
Nijmegen, Netherlands
UMCU
Utrecht, Netherlands