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Trial record 58 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897596
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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.

Condition or disease Intervention/treatment 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

Detailed Description:

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
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
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : April 28, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


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 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




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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897596


Locations
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Spain
Hospital Clínico y provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica

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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
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MK-5172
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents