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
Verified March 2017 by Taoyuan General Hospital
Taoyuan General Hospital
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
Taoyuan General Hospital
First received: March 27, 2017
Last updated: March 30, 2017
Last Verified: March 2017
History of Changes
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.
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
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
- Severe adverse effects
[ Time Frame: during the treatment of grazoprevir and elbasvir ]
The frequency of severe adverse effects leading to discontinuation
|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)|
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
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.
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.
•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.
|Ages Eligible for Study:||20 Years to 80 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
Contacts and LocationsChoosing 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
|Contact: Chien-Yu Cheng||+88633699721 ext firstname.lastname@example.org|
Sponsors and CollaboratorsTaoyuan General Hospital
Merck Sharp & Dohme Corp.
|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:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.