Dutch Acute HCV in HIV Study (DAHHS) (DAHHS)
|ClinicalTrials.gov Identifier: NCT01912495|
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Human Immunodeficiency Virus||Drug: Boceprevir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||January 2016|
Experimental: Boceprevir, peginterferon ribavirin
All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.
Other Name: Victrelis
- 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 ]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 ]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 ]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 ]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 ]
- Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. [ Time Frame: 72 weeks ]only serious adverse events are recorded in this secondary endpoint
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912495
|Rotterdam, Zuid Holland, Netherlands, 3000CA|
|Principal Investigator:||Bart Rijnders, MD, PhD||Erasmus MC|