Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients (EARLY-HEP-C)

February 13, 2019 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínico y Provincial de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years of age
  • Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (> 10.000 IU/mL) and anti-HCV seroconversion.
  • No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
  • Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result <8 kPa
  • Be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
  • Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir

Exclusion Criteria:

  • < 18 years of age
  • Patients with chronic hepatitis C genotypes other than 1 or 4.
  • History of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
  • Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result > 8kPa
  • Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
  • Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, Inhibitors or Protease Inhibitors against HIV will be not allow.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genotype 1b
Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
Drug: Grazoprevir 100 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Other Names:
  • MK-5172 100 mg
Drug: Elbasvir 50 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Other Names:
  • MK-8742 50 mg
Experimental: Genotype 1a and 4
Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
Drug: Grazoprevir 100 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Other Names:
  • MK-5172 100 mg
Drug: Elbasvir 50 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
Other Names:
  • MK-8742 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response.
Time Frame: 24 weeks
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reinfection rate
Time Frame: 1 year
Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
1 year
Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
Time Frame: 2 years
number of adverse events treatment-related assess in 62 patients.
2 years
Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
Time Frame: 2 years
In case of viral failure confirmation during the follow up, viral resistence-associated variants will be assess by samples genotyping HCV protease and NS5A gene at baseline and after the viral failure.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Anticipated)

April 28, 2019

Study Completion (Anticipated)

October 30, 2019

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EARLY-HEP-C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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