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Trial record 2 of 3 for:    15282351 [PUBMED-IDS]

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

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

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: grazoprevir and elbasvir Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ribavirin

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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 :
  1. Severe adverse effects [ Time Frame: during the treatment of grazoprevir and elbasvir ]
    The frequency of severe adverse effects leading to discontinuation



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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.

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): NCT03098121


Locations
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Taiwan
Taoyuan general hospital
Taoyuan, Taiwan, 33004
Sponsors and Collaborators
Taoyuan General Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Chien-Yu Cheng Taoyuan General Hospital

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taoyuan General Hospital
ClinicalTrials.gov Identifier: NCT03098121     History of Changes
Other Study ID Numbers: TYGH105034
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
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

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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:
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Coinfection
Hepatitis C
Hepatitis C, Chronic
HIV Infections
Infection
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Parasitic Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ribavirin
MK-5172
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents