Dutch Acute HCV in HIV Study (DAHHS)

This study is currently recruiting participants.
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

July 29, 2013
February 19, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
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 ]
Sustaine Viral Respons(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 ]
Complete list of historical versions of study NCT01912495 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dutch Acute HCV in HIV Study (DAHHS)
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.

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Human Immunodeficiency Virus
Drug: Boceprevir
Other Name: Victrelis
Experimental: Boceprevir
Intervention: Drug: Boceprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bas Hullegie, MD +31613088212 b.hullegie@erasmusmc.nl
Contact: Bart Rijnders, MD, PhD +31107033510 b.rijnders@erasmusmc.nl
Netherlands
 
NCT01912495
NL44825.078.13
No
Bart Rijnders, Erasmus Medical Center
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
Principal Investigator: Bart Rijnders, MD, PhD Erasmus MC
Erasmus Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP