Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified August 2016 by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Sponsor
Fundacion Clinic per a la Recerca Biomédica


Information provided by (Responsible Party)
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

ClinicalTrials.gov Identifier
NCT02897596

First received: August 22, 2016
Last updated: September 7, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Hepatitis C
HIV

Drug : Grazoprevir 100 mg/d 8 weeks
Drug : Elbasvir 50 mg/d 8 weeks
Drug : Grazoprevir 100 mg/d 12 weeks
Drug : Elbasvir 50 mg/d 12 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

Further study details as provided by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures

  • Sustained virological response. [ Time Frame: 24 weeks ]
    Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
Secondary Outcome Measures:
  • 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.
  • 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.
  • 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.

Estimated Enrollment: 62
Study Start Date: September 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: MK-8742 50 mg

Detailed Description:

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir
Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02897596

Contacts

Contact:   Josep Mallolas, Doctor +34 932275430 acruceta@clinic.cat
Contact:   ana cruceta 609511942

Sponsors and Collaborators

Fundacion Clinic per a la Recerca Biomédica
More Information

More Information


Responsible Party: Anna Cruceta, Project manager, Fundacion Clinic per a la Recerca Biomédica  
ClinicalTrials.gov Identifier: NCT02897596   History of Changes  
Other Study ID Numbers: EARLY-HEP-C  
Study First Received: August 22, 2016  
Last Updated: September 7, 2016  

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.