Dutch Acute HCV in HIV Study (DAHHS) (DAHHS)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of 12 Week Boceprevir in Addition to Standard of Care Therapy Consisting of Peginterferon-alpha-2b and Ribavirin for the Treatment of Acute HCV Genotype 1 in HIV Co-infected Patients. A Proof of Concept Feasibility Clinical Trial.|
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy
- SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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
- SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]only serious adverse events are recorded in this secondary endpoint
|Study Start Date:||August 2013|
|Study Completion Date:||January 2016|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Boceprevir, peginterferon ribavirin
All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.
Other Name: Victrelis
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912495
|Rotterdam, Zuid Holland, Netherlands, 3000CA|
|Principal Investigator:||Bart Rijnders, MD, PhD||Erasmus MC|