Trials / Completed
CompletedNCT02105662
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)
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets | MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg) |
Timeline
- Start date
- 2014-06-03
- Primary completion
- 2015-02-20
- Completion
- 2015-05-22
- First posted
- 2014-04-07
- Last updated
- 2021-02-05
- Results posted
- 2016-03-04
Source: ClinicalTrials.gov record NCT02105662. Inclusion in this directory is not an endorsement.