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Trial record 3 of 11 for:    merck mk5172 hiv

Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

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: NCT03098121
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Taoyuan General Hospital

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE October 20, 2017
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Severe adverse effects [ Time Frame: during the treatment of grazoprevir and elbasvir ]
The frequency of severe adverse effects leading to discontinuation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE Drug: grazoprevir and elbasvir
For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir 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 and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Study Arms  ICMJE Experimental: Genotype 1 HCV and HIV co-infection
Patients with chronic Genotype 1 HCV and HIV co-infection, with or without resistance-associated substitution (RAS) of NS5A, received grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and patients with chronic genotype 1b received grazoprevir and elbasvir once daily for 12 weeks.
Intervention: Drug: grazoprevir and elbasvir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098121
Other Study ID Numbers  ICMJE TYGH105034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The study will be conducted at 3 different hospitals, and the investigators will share the data with other researchers every 3 months
Supporting Materials: Study Protocol
Time Frame: The data will become available in March 2019.
Access Criteria: The investigators will share the data and outcome via international conference
Responsible Party Taoyuan General Hospital
Study Sponsor  ICMJE Taoyuan General Hospital
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Principal Investigator: Chien-Yu Cheng Taoyuan General Hospital
PRS Account Taoyuan General Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP