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Liver CirrhosisNCT02693847

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

An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Hospital Universitario de Valme at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis, Hepatocellular Carcinoma, HIV
How many people
446 participants
Where
8 sitesSpain
Study dates
Feb 2006to Dec 2020
How long will I take part?
10 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital Universitario Reina Sofía

    Córdoba

  • Complejo Hospitalario de Huelva

    Huelva

  • Complejo Hospitalario de Jaén

    Jaén

  • Hospital de La Línea de la Concepción

    La Línea de la Concepción, Cádiz

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario de Puerto Real

    Puerto Real, Cádiz

  • Hospital Universitario de Valme

    Seville, 41011

  • Hospital Universitario Virgen Macarena

    Seville, 41011

Other trials in Spain

About this study

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.

Keywords
HCV, HIV, Liver cirrhosis, Hepatocellular carcinoma, Liver transplant, Liver stiffness, Transient elastography
Medical subject headings
Liver Cirrhosis, Carcinoma, Hepatocellular

What is being measured

The primary outcome is the main question the study is designed to answer.

  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,…)

    Measured: 3 years

Secondary outcomes (2)

  1. Liver-related mortality

    Probability of liver-related death after enrollment

    Measured: 3 Years

  2. All cause mortality

    Probability of death of any cause

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2016 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
446 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02693847
Sponsor's protocol ID
HEPAVIR-Cirrhosis Cohort
Status last verified
Feb 2021
First submitted
24 Nov 2015
Last updated
26 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22278746

  • 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.

    PubMed 22405076

  • 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.

    PubMed 19487952

  • 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.

    PubMed 26643257

  • 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.

    PubMed 27922855

  • 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.

    PubMed 28783247

  • 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.

    PubMed 29982683

  • 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.

    PubMed 31813962

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Hospital Universitario de Valme at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02693847, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.

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