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Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT02897596•Fundacion Clinic per a la Recerca Biomédica

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.

Detailed Description

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital Clínico y provincial de Barcelona

Barcelona, Spain

Key Dates

Start Date

April 28, 2017

Primary Completion Date

April 28, 2019

Completion Date

October 30, 2019

Last Updated

February 15, 2019

Enrollment

ESTIMATED participants

Conditions

Hepatitis CHIV

Interventions

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

DRUG

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Thinking and Memory Problems in People With HIV

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Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption