NCT01912495

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Boceprevir

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2016-01-01
• First posted: 2013-07-31
• Last updated: 2016-04-01
• Results posted: 2016-04-01

Locations

9 sites across 1 country: Netherlands