Clinical Trials

MainTitle

Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial

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

Verified March 2017 by Taoyuan General Hospital

Sponsor
Taoyuan General Hospital

Collaborator
Merck Sharp & Dohme Corp.

Information provided by (Responsible Party)
Taoyuan General Hospital
ClinicalTrials.gov Identifier
NCT03098121

First received: March 27, 2017
Last updated: March 30, 2017
Last Verified: March 2017
History of Changes
Purpose

Purpose

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

Condition Intervention Phase
To Assess the Efficacy of Grazoprevir 100mg and Elbasvir 50mg by Determining the Proportion of Sustained Virological Response 12 Weeks After the End of Therapy

Drug : grazoprevir and elbasvir
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Grazoprevir and Elbasvir in Peginterferon Alfa Plus Ribavirin Experienced Patients With Chronic Genotype 1 HCV and HIV Co-infection: a Non-randomised, Open-label Clinical Trial

Further study details as provided by Taoyuan General Hospital:

Primary Outcome Measures

  • Sustained virological response [ Time Frame: 12 weeks after the end of therapy ]
    The proportion of sustained virological response 12 weeks after the end of therapy after the treatment of grazoprevir and elbasvir
Secondary Outcome Measures:
  • Severe adverse effects [ Time Frame: during the treatment of grazoprevir and elbasvir ]
    The frequency of severe adverse effects leading to discontinuation

Estimated Enrollment: 40
Study Start Date: June 20, 2017
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: peginterferon experienced patients with genotype 1
Intervention is to add grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV co-infection
Drug: grazoprevir and elbasvir

For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir 100mg and elbasvir 50mg in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir 100mg and elbasvir 50mg in a fixed-dose combination tablet once daily for 12 weeks.

Detailed Description:

Primary Objective •To assess the efficacy of grazoprevir 100mg and elbasvir 50mg by determining the proportion of sustained virological response 12 weeks after the end of therapy (SVR12; HCV RNA concentration less than 10 IU/ mL at follow-up week 12) in peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV co-infection, compared with treatment-naïve patients with 1 HCV and HIV co-infection.
Secondary Objective
•To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of SAEs and AEs leading to discontinuation.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 80 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Men and non-pregnant women, at least 20 years of age with chronic genotype 1 HCV and HIV co-infection.
  • HCV RNA > 10,000 IU/mL
  • Stable antiretroviral therapy (ARV) with confirmed plasma HIV-1 RNA < 200 copies/mL
  • CD4 T-cell count > 100 cells/L
  • peginterferon alfa plus ribavirin failure: null response <1 log10 IU/mL reduction in HCV RNA at week 4; detectable HCV RNA since week 12 to the end of treatment; detectable HCV RNA for 12 to 24 weeks after the end of treatment; or discontinuation of peginterferon alfa plus ribavirin due to grade 3 or grade 4 adverse effects at any moment.


Exclusion Criteria:
  • Decompensated liver disease (presence or history of ascites, oesophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs of advanced liver diseases)
  • Liver cirrhosis with Child-Pugh class B or C, or with a Child-Turcotte-Pugh score of more than 6 points and albumin below 3 g/dL or platelet count below 75,000/ μL
  • History of malignant disease, or evidence of hepatocellular carcinoma
  • ARV with protease inhibitor containing regimen HBsAg and HBV core antibody should be
checked in all patients. HBsAg positive patients should be excluded from the study. HBV core antibody positive patients should be closely monitored for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate patient management should be instituted for HBV infection as clinically indicated.

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: NCT03098121

Contacts

Contact:   Chien-Yu Cheng +88633699721 ext 8311 vajien@mail.tygh.gov.tw

Sponsors and Collaborators

Taoyuan General Hospital
Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Taoyuan General Hospital  
ClinicalTrials.gov Identifier: NCT03098121   History of Changes  
Other Study ID Numbers: TYGH105034  
Study First Received: March 27, 2017  
Last Updated: March 30, 2017  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: Yes  

Additional relevant MeSH terms:
Coinfection
Ribavirin

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