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Dutch Acute HCV in HIV Study (DAHHS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Erasmus Medical Center
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Onze Lieve Vrouwe Gasthuis
UMC Utrecht
University Medical Centre Groningen
Maastricht University Medical Center
Rijnstate Hospital
Slotervaart Hospital
UMCN
Information provided by (Responsible Party):
Bart Rijnders, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01912495
First received: July 29, 2013
Last updated: February 19, 2014
Last verified: February 2014
  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 Responds(SVR) at 24 weeks of follow up after the end of all therapy for the Rapid Viral Response at week 4(RVR4) population. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR 24 weeks after the end of all therapy in the entire study population (with or without RVR4). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • SVR 12 weeks after end of therapy in RVR4 population. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SVR 24 weeks after end of therapy in patients with already a RVR at week 1. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • SVR 24 weeks after end of therapy in patients that started therapy ≤12weeks after the presumed HCV infection date versus those after 12 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boceprevir Drug: Boceprevir
Other Name: Victrelis

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Bas Hullegie, MD +31613088212 b.hullegie@erasmusmc.nl
Contact: Bart Rijnders, MD, PhD +31107033510 b.rijnders@erasmusmc.nl

Locations
Netherlands
Erasmus MC Recruiting
Rotterdam, Zuid Holland, Netherlands, 3000CA
Contact: Mark Claassen, MD, PhD       m.claassen@erasmusmc.nl   
Principal Investigator: Bart Rijnders, MD, PhD         
Sub-Investigator: Marc Claassen         
Sub-Investigator: Bas Hullegie         
AMC Recruiting
Amsterdam, Netherlands
Contact: Jan van der Meer    0031 205669111    j.t.vandermeer@amc.uva.nl   
Principal Investigator: Jan van den Meer         
OLVG Recruiting
Amsterdam, Netherlands
Contact: Guido Van den Berk    0031 205993501    G.E.L.vandenBerk@olvg.nl   
Principal Investigator: Guido Van den Berk         
Slotervaart Recruiting
Amsterdam, Netherlands
Contact: Fanny Lauw       Fanny.lauw@slz.nl   
Principal Investigator: Fanny lauw         
Ziekenhuis Rijnstate Recruiting
Arnhem, Netherlands
Contact: Clemens Richter       crichter@rijnstate.nl   
UMCG Recruiting
Groningen, Netherlands
Contact: Wouter Bierman       w.f.w.bierman@umcg.nl   
Principal Investigator: Sander van Assen         
MUMC Recruiting
Maastricht, Netherlands
Contact: dirk posthouwer       d.posthouwer@mumc.nl   
Principal Investigator: dirk posthouwer         
Radboud UMCN Recruiting
Nijmegen, Netherlands
Contact: Peter Koopmans    0031243616498    p.koopmans@aig.umcn.nl   
UMCU Recruiting
Utrecht, Netherlands
Contact: Joop Arends    0031 88 7555555 ext 1180    j.e.arends@umcutrecht.nl   
Principal Investigator: Joop Arends         
Sponsors and Collaborators
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Onze Lieve Vrouwe Gasthuis
UMC Utrecht
University Medical Centre Groningen
Maastricht University Medical Center
Rijnstate Hospital
Slotervaart Hospital
UMCN
Investigators
Principal Investigator: Bart Rijnders, MD, PhD Erasmus MC
  More Information

No publications provided

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
Last Updated: February 19, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis C
Immunologic Deficiency Syndromes
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Immune System Diseases
Lentivirus Infections
Liver Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014