CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Boceprevirdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01912495
NCT01912495Phase 2Completed

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.

Erasmus Medical Center·interventional·Posted Jul 31, 2013·Updated Apr 1, 2016

In Brief

A Phase 2 clinical trial evaluating Boceprevir for Hepatitis C and Human Immunodeficiency Virus. Completed, enrolled 65 participants across 9 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 31, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.9 years ago

Interventions

Boceprevirdrug