Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

February 24, 2021 updated by: Nicolás Merchante, Hospital Universitario de Valme
Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Huelva, Spain
        • Complejo Hospitalario de Huelva
      • Jaén, Spain
        • Complejo Hospitalario de Jaen
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41011
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41011
        • Hospital Universitario de Valme
    • Cádiz
      • La Línea de la Concepción, Cádiz, Spain
        • Hospital de la Linea de la Concepcion
      • Puerto Real, Cádiz, Spain
        • Hospital Universitario de Puerto Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV/HCV-coinfected patients diagnosed of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals

Description

Inclusion Criteria:

  • HIV Infection
  • HCV chronic active infection (positive serum RNA HCV at inclusion)
  • New diagnosis of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals.
  • No previous or concomitant decompensation of liver disease

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up
Time Frame: 3 years
Episodes of liver decompensation will include those episodes of ascites, spontaneous bacterial peritonitis, portal hypertensive gastrointestinal bleeding, hepatorrenal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non obstructive jaundice and acute on chronic liver failure. These episodes will be diagnosed according to standard definitions of clinical practice guidelines in the field (i.e. HCC diagnosis will be diagnosed according to AASLD criteria, spontaneous bacterial peritonitis and hepatorenal syndrome will be diagnosed following the EASL criteria, portal hypertensive gastrointestinal bleeding according Baveno VI consensus definition,…)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver-related mortality
Time Frame: 3 Years
Probability of liver-related death after enrollment
3 Years
All cause mortality
Time Frame: 3 Years
Probability of death of any cause
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Valme

Collaborators

Hospital Universitario Virgen Macarena
Hospital Universitario Reina Sofia de Cordoba
Hospital Universitario Virgen de la Victoria
Hospital Universitario Puerto Real
Complejo Hospitalario Universitario de Huelva
Hospital de La Línea
Complejo Hospitalario de Jaen

Investigators

  • Principal Investigator: Nicolás Merchante, MD PhD, Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

February 23, 2016

First Posted (ESTIMATE)

February 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPAVIR-Cirrhosis Cohort

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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