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

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Bart Rijnders, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01912495
First received: July 29, 2013
Last updated: March 2, 2016
Last verified: March 2016
  Purpose

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 Intervention Phase
Hepatitis C
Human Immunodeficiency Virus
Drug: Boceprevir
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

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. [ 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.


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: August 2013
Study Completion Date: January 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boceprevir, peginterferon ribavirin
All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.
Drug: Boceprevir
Other Name: Victrelis

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912495

Locations
Netherlands
Erasmus MC
Rotterdam, Zuid Holland, Netherlands, 3000CA
AMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Slotervaart
Amsterdam, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
UMCG
Groningen, Netherlands
MUMC
Maastricht, Netherlands
Radboud UMCN
Nijmegen, Netherlands
UMCU
Utrecht, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
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
Investigators
Principal Investigator: Bart Rijnders, MD, PhD Erasmus MC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bart Rijnders, MD,PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01912495     History of Changes
Other Study ID Numbers: NL44825.078.13 
Study First Received: July 29, 2013
Results First Received: December 7, 2015
Last Updated: March 2, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Hepatitis C
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 07, 2016