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Dutch Acute HCV in HIV Study (DAHHS)

NCT01912495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2016-04-01

Study results available
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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.

Conditions

  • Hepatitis C
  • Human Immunodeficiency Virus

Interventions

DRUG

Boceprevir

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Onze Lieve Vrouwe Gasthuis

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Rijnstate Hospital

    collaborator OTHER

  • Slotervaart Hospital

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Bart Rijnders, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-08-31
Completion
2016-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912495 on ClinicalTrials.gov