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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2017 by Nicolás Merchante, Hospital Universitario de Valme

Sponsor
Hospital Universitario de Valme

Collaborator
Hospital Universitario Virgen Macarena
Complejo Hospitalario Universitario de Huelva
Hospital de La Línea
Hospital Universitario Reina Sofia
Hospital Universitario Virgen de la Victoria
Complejo Hospitalario de Jaén

Information provided by (Responsible Party)
Nicolás Merchante, Hospital Universitario de Valme

ClinicalTrials.gov Identifier
NCT02693847

First received: November 24, 2015
Last updated: August 16, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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.

Condition
Liver Cirrhosis
Hepatocellular Carcinoma
HIV
HCV Coinfection

Study Type: Observational [Patient Registry]
Study Design:
Official Title: Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Further study details as provided by Nicolás Merchante, Hospital Universitario de Valme:

Primary Outcome Measures

  • 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,…)
Secondary Outcome Measures:
  • Liver-related mortality [ Time Frame: 3 Years ]
    Probability of liver-related death after enrollment
  • All cause mortality [ Time Frame: 3 Years ]
    Probability of death of any cause

Biospecimen Retention: Samples Without DNA
Serum samples are collected and immediately frozen for criopreservation

Estimated Enrollment: 446
Study Start Date: February 2006
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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

Criteria

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:

contacts and locations

Contacts and Locations

Choosing 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: NCT02693847

Contacts

Contact:   Nicolás Merchante, MD PhD 0034-955015684 nicolasmerchante@gmail.com
Contact:   Juan Antonio Pineda, MD PhD 0034-955015684 japineda@telefonica.net

Locations

Spain
Hospital de La Línea de la Concepción Recruiting
La Línea de la Concepción, Cádiz, Spain
Contact: Francisco Téllez
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Antonio Rivero-Juárez
Complejo Hospitalario de Huelva Recruiting
Huelva, Spain
Contact: Dolores Merino
Complejo Hospitalario de Jaén Recruiting
Jaén, Spain
Contact: Mohamed Omar
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Manuel Márquez Solero
Hospital Universitario de Valme Recruiting
Sevilla, Spain, 41011
Contact: Nicolás Merchante, MD PhD    0034-955015684    nicolasmerchante@gmail.com
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41011
Contact: Maria J. Rios

Sponsors and Collaborators

Hospital Universitario de Valme
Hospital Universitario Virgen Macarena
Complejo Hospitalario Universitario de Huelva
Hospital de La Línea
Hospital Universitario Reina Sofia
Hospital Universitario Virgen de la Victoria
Complejo Hospitalario de Jaén

Investigators

Principal Investigator: Nicolás Merchante, MD PhD Andaluz Health Service
More Information

More Information


Responsible Party: Nicolás Merchante, MD, PhD, Hospital Universitario de Valme  
ClinicalTrials.gov Identifier: NCT02693847   History of Changes  
Other Study ID Numbers: HEPAVIR-Cirrhosis Cohort  
Study First Received: November 24, 2015  
Last Updated: August 16, 2017  

Keywords provided by Nicolás Merchante, Hospital Universitario de Valme:

HCV
HIV
Liver cirrhosis
Hepatocellular carcinoma
Liver transplant
Liver stiffness
Transient elastography

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Coinfection

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.