NCT01912495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

July 29, 2013

Results QC Date

December 7, 2015

Last Update Submit

March 2, 2016

Conditions

Hepatitis CHuman Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (5)

  • SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).

    12 weeks

  • SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.

    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.

    12 weeks

  • Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.

    72 weeks

  • Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.

    72 weeks

Study Arms (1)

Boceprevir, peginterferon ribavirin

EXPERIMENTAL

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

Drug: Boceprevir

Interventions

BoceprevirDRUG
Also known as: Victrelis
Boceprevir, peginterferon ribavirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Erasmus MC

Rotterdam, South Holland, 3000CA, Netherlands

Location

AMC

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Slotervaart

Amsterdam, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, Netherlands

Location

UMCG

Groningen, Netherlands

Location

MUMC

Maastricht, Netherlands

Location

Radboud UMCN

Nijmegen, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 36146760DERIVED

  • 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.

    PMID: 26689767DERIVED

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency Syndrome

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
B.J.A.Rijnders
Organization
Erasmus MC
b.rijnders@erasmusmc.nl
0031107034529

Study Officials

  • Bart Rijnders, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

April 1, 2016

Results First Posted

April 1, 2016

Record last verified: 2016-03

Locations

NL(9)