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Dutch Acute HCV in HIV Study (DAHHS) (DAHHS)

Primary Purpose

Hepatitis C, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Boceprevir
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
  2. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml.
  3. A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old.
  4. On HAART at the time of screening.
  5. Minimum age 18 years.

Exclusion Criteria:

  1. Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used.
  2. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine clearance <50ml/min).
  3. History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening.
  4. HAART was started <4 weeks before baseline visit.
  5. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.
  6. Patient that virologically failed HAART in the past

Sites / Locations

  • Erasmus MC
  • AMC
  • OLVG
  • Slotervaart
  • Ziekenhuis Rijnstate
  • UMCG
  • MUMC
  • Radboud UMCN
  • UMCU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boceprevir, peginterferon ribavirin

Arm Description

All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.
Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.
only serious adverse events are recorded in this secondary endpoint

Full Information

First Posted
July 29, 2013
Last Updated
March 2, 2016
Sponsor
Erasmus Medical Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Onze Lieve Vrouwe Gasthuis, UMC Utrecht, University Medical Center Groningen, Maastricht University Medical Center, Rijnstate Hospital, Slotervaart Hospital, Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01912495
Brief Title
Dutch Acute HCV in HIV Study (DAHHS)
Acronym
DAHHS
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Onze Lieve Vrouwe Gasthuis, UMC Utrecht, University Medical Center Groningen, Maastricht University Medical Center, Rijnstate Hospital, Slotervaart Hospital, Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boceprevir, peginterferon ribavirin
Arm Type
Experimental
Arm Description
All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
Victrelis
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).
Description
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
Title
SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.
Description
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
Title
SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.
Description
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
Title
Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.
Time Frame
72 weeks
Title
Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.
Description
only serious adverse events are recorded in this secondary endpoint
Time Frame
72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml. A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old. On HAART at the time of screening. Minimum age 18 years. Exclusion Criteria: Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine clearance <50ml/min). History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening. HAART was started <4 weeks before baseline visit. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD. Patient that virologically failed HAART in the past
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Rijnders, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3000CA
Country
Netherlands
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
Slotervaart
City
Amsterdam
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
MUMC
City
Maastricht
Country
Netherlands
Facility Name
Radboud UMCN
City
Nijmegen
Country
Netherlands
Facility Name
UMCU
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
36146760
Citation
Popping S, Cuypers L, Claassen MAA, van den Berk GE, De Weggheleire A, Arends JE, Boerekamps A, Molenkamp R, Koopmans MPG, Verbon A, Boucher CAB, Rijnders B, van de Vijver DAMC. Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals. Viruses. 2022 Sep 2;14(9):1953. doi: 10.3390/v14091953.
Results Reference
derived
PubMed Identifier
26689767
Citation
Hullegie SJ, Claassen MA, van den Berk GE, van der Meer JT, Posthouwer D, Lauw FN, Leyten EM, Koopmans PP, Richter C, van Eeden A, Bierman WF, Newsum AM, Arends JE, Rijnders BJ. Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients. J Hepatol. 2016 Apr;64(4):807-12. doi: 10.1016/j.jhep.2015.12.004. Epub 2015 Dec 12.
Results Reference
derived

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Dutch Acute HCV in HIV Study (DAHHS)

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