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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02693847

Enrollment

446

Registered

2016-02-29

Start date

2006-02-28

Completion date

2020-12-31

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Coinfection, Hepatocellular Carcinoma, HIV, Liver Cirrhosis

Keywords

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

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up	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

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

Countries

Spain

Outcome results