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

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.

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Key information

Conditions

Liver Cirrhosis Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis HCV Coinfection HIV Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de La Línea de la Concepción, La Línea de la Concepción, Cádiz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Valme

Other

Collaborators

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

Registry information

Important dates

Study start: 2006
Primary completion: 2020
Study completion: 2020
First posted: Feb 29, 2016
Registry last updated: Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed