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

Completed

• Conditions: HCV Coinfection; Liver Cirrhosis; HIV; Hepatocellular Carcinoma

• Registration Number: NCT02693847
• Lead Sponsor: Hospital Universitario de Valme

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Liver-related mortality	3 Years	Probability of liver-related death after enrollment
All cause mortality	3 Years	Probability of death of any cause

Trial Locations

Locations (8)

Hospital de La Línea de la Concepción; 🇪🇸 La Línea de la Concepción, Cádiz, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital Universitario de Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain

Complejo Hospitalario de Huelva; 🇪🇸 Huelva, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario de Valme; 🇪🇸 Sevilla, Spain