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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

446

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14.8 years study duration

Study Start

First participant enrolled

February 1, 2006

Completed

9.8 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed

3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed

Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

14.8 years

First QC Date

November 24, 2015

Last Update Submit

February 24, 2021

Conditions

Liver Cirrhosis Hepatocellular Carcinoma HIV HCV Coinfection

Keywords

HCVHIVLiver cirrhosisHepatocellular carcinomaLiver transplantLiver stiffnessTransient elastography

Outcome Measures

Primary Outcomes (1)

Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up
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 Outcomes (2)

Liver-related mortality
3 Years
All cause mortality
3 Years

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

HIV Infection
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

Contact the study team to confirm eligibility.

Study Sites (8)

Hospital de La Línea de la Concepción

La Línea de la Concepción, Cádiz, Spain

Location

Hospital Universitario de Puerto Real

Puerto Real, Cádiz, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Complejo Hospitalario de Huelva

Huelva, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario de Valme

Seville, 41011, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41011, Spain

Location

Related Publications (8)

Merchante N, Rivero-Juarez A, Tellez F, Merino D, Jose Rios-Villegas M, Marquez-Solero M, Omar M, Macias J, Camacho A, Perez-Perez M, Gomez-Mateos J, Rivero A, Antonio Pineda J; Grupo Andaluz para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Liver stiffness predicts clinical outcome in human immunodeficiency virus/hepatitis C virus-coinfected patients with compensated liver cirrhosis. Hepatology. 2012 Jul;56(1):228-38. doi: 10.1002/hep.25616. Epub 2012 Jun 6.
PMID: 22278746RESULT
Recio E, Macias J, Rivero-Juarez A, Tellez F, Merino D, Rios M, Marquez M, Omar M, Rivero A, Lorenzo S, Merchante N, Pineda JA. Liver stiffness correlates with Child-Pugh-Turcotte and MELD scores in HIV/hepatitis C virus-coinfected patients with cirrhosis. Liver Int. 2012 Jul;32(6):1031-2. doi: 10.1111/j.1478-3231.2012.02782.x. Epub 2012 Mar 9. No abstract available.
PMID: 22405076RESULT
Pineda JA, Recio E, Camacho A, Macias J, Almodovar C, Gonzalez-Serrano M, Merino D, Tellez F, Rios MJ, Rivero A; Grupo Andaluz de Hepatitis Virica (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Liver stiffness as a predictor of esophageal varices requiring therapy in HIV/hepatitis C virus-coinfected patients with cirrhosis. J Acquir Immune Defic Syndr. 2009 Aug 1;51(4):445-9. doi: 10.1097/QAI.0b013e3181acb675.
PMID: 19487952RESULT
Merchante N, Tellez F, Rivero-Juarez A, Rios-Villegas MJ, Merino D, Marquez-Solero M, Omar M, Recio E, Perez-Perez M, Camacho A, Macias-Dorado S, Macias J, Lorenzo-Moncada S, Rivero A, Pineda JA; Grupo Andaluz para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Progression of liver stiffness predicts clinical events in HIV/HCV-coinfected patients with compensated cirrhosis. BMC Infect Dis. 2015 Dec 7;15:557. doi: 10.1186/s12879-015-1291-3.
PMID: 26643257RESULT
Merchante N, Rivero-Juarez A, Tellez F, Merino D, Rios-Villegas MJ, Ojeda-Burgos G, Omar M, Macias J, Rivero A, Perez-Perez M, Raffo M, Lopez-Montesinos I, Marquez-Solero M, Gomez-Vidal MA, Pineda JA; Grupo Andaluz para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Liver stiffness predicts variceal bleeding in HIV/HCV-coinfected patients with compensated cirrhosis. AIDS. 2017 Feb 20;31(4):493-500. doi: 10.1097/QAD.0000000000001358.
PMID: 27922855RESULT
Merchante N, Aldamiz-Echevarria T, Garcia-Alvarez M, Rivero-Juarez A, Macias J, Miralles P, Jimenez-Sousa MA, Mancebo M, Perez-Latorre L, Pineda-Tenor D, Berenguer J, Resino S, Pineda JA. Bacterial translocation and clinical progression of HCV-related cirrhosis in HIV-infected patients. J Viral Hepat. 2018 Feb;25(2):180-186. doi: 10.1111/jvh.12769. Epub 2017 Sep 7.
PMID: 28783247RESULT
Merchante N, Rivero-Juarez A, Tellez F, Merino D, Rios-Villegas MJ, Villalobos M, Omar M, Rincon P, Rivero A, Perez-Perez M, Raffo M, Lopez-Montesinos I, Palacios R, Gomez-Vidal MA, Macias J, Pineda JA; Members of the HEPAVIR-Cirrhosis Study Group. Sustained virological response to direct-acting antiviral regimens reduces the risk of hepatocellular carcinoma in HIV/HCV-coinfected patients with cirrhosis. J Antimicrob Chemother. 2018 Sep 1;73(9):2435-2443. doi: 10.1093/jac/dky234.
PMID: 29982683RESULT
Merchante N, Saroli Palumbo C, Mazzola G, Pineda JA, Tellez F, Rivero-Juarez A, Rios-Villegas MJ, Maurice JB, Westbrook RH, Judge R, Guaraldi G, Schepis F, Perazzo H, Rockstroh J, Boesecke C, Klein MB, Cervo A, Ghali P, Wong P, Petta S, De Ledinghen V, Macias J, Sebastiani G. Prediction of Esophageal Varices by Liver Stiffness and Platelets in Persons With Human Immunodeficiency Virus Infection and Compensated Advanced Chronic Liver Disease. Clin Infect Dis. 2020 Dec 31;71(11):2810-2817. doi: 10.1093/cid/ciz1181.
PMID: 31813962RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples are collected and immediately frozen for criopreservation

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

Nicolás Merchante, MD PhD
Andaluz Health Service
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 10 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD

Study Record Dates

First Submitted

November 24, 2015

First Posted

February 29, 2016

Study Start

February 1, 2006

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

ES(8)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (8)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (8)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations