Dutch Acute HCV in HIV Study (DAHHS) (DAHHS)
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|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
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): NCT01912495
|Rotterdam, Zuid Holland, Netherlands, 3000CA|
|Principal Investigator:||Bart Rijnders, MD, PhD||Erasmus MC|