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

Primary Purpose

Hepatitis C, HIV

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Grazoprevir 100 mg/d 8 weeks
Elbasvir 50 mg/d 8 weeks
Grazoprevir 100 mg/d 12 weeks
Elbasvir 50 mg/d 12 weeks
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínico y provincial de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Genotype 1b

Genotype 1a and 4

Arm Description

Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.

Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.

Outcomes

Primary Outcome Measures

Sustained virological response.
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.

Secondary Outcome Measures

Reinfection rate
Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
number of adverse events treatment-related assess in 62 patients.
Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
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.

Full Information

First Posted
August 22, 2016
Last Updated
February 13, 2019
Sponsor
Fundacion Clinic per a la Recerca Biomédica
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1. Study Identification

Unique Protocol Identification Number
NCT02897596
Brief Title
Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
Acronym
EARLY-HEP-C
Official Title
Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
April 28, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genotype 1b
Arm Type
Experimental
Arm Description
Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
Arm Title
Genotype 1a and 4
Arm Type
Experimental
Arm Description
Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Grazoprevir 100 mg/d 8 weeks
Other Intervention Name(s)
MK-5172 100 mg
Intervention Description
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Elbasvir 50 mg/d 8 weeks
Other Intervention Name(s)
MK-8742 50 mg
Intervention Description
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Grazoprevir 100 mg/d 12 weeks
Other Intervention Name(s)
MK-5172 100 mg
Intervention Description
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Elbasvir 50 mg/d 12 weeks
Other Intervention Name(s)
MK-8742 50 mg
Intervention Description
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
Primary Outcome Measure Information:
Title
Sustained virological response.
Description
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Reinfection rate
Description
Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
Time Frame
1 year
Title
Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
Description
number of adverse events treatment-related assess in 62 patients.
Time Frame
2 years
Title
Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clínico y provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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