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An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)

NCT02105662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-02-05

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets

MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-03
Primary Completion
2015-02-20
Completion
2015-05-22

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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 NCT02105662 on ClinicalTrials.gov