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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693847
• Other study ID #: HEPAVIR-Cirrhosis Cohort
• Status: Completed
• Start date: February 2006
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: Hospital Universitario de Valme
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Coinfection
• Fibrosis
• HCV Coinfection
• Hepatocellular Carcinoma
• HIV
• Liver Cirrhosis

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Complejo Hospitalario de Huelva	Huelva
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital de La Línea de la Concepción	La Línea de la Concepción	Cádiz
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario de Puerto Real	Puerto Real	Cádiz
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (8)

Lead Sponsor	Collaborator
Hospital Universitario de Valme	Complejo Hospitalario de Jaén, Complejo Hospitalario Universitario de Huelva, Hospital de La Línea, Hospital Universitario Puerto Real, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Victoria, Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Merchante N, Aldámiz-Echevarría T, García-Álvarez M, Rivero-Juárez A, Macías J, Miralles P, Jiménez-Sousa MA, Mancebo M, Pérez-Latorre L, Pineda-Tenor D, Berenguer J, Resino S, Pineda JA. Bacterial translocation and clinical progression of HCV-related cir — View Citation

Merchante N, Rivero-Juárez A, Téllez F, Merino D, José Ríos-Villegas M, Márquez-Solero M, Omar M, Macías J, Camacho A, Pérez-Pérez M, Gómez-Mateos J, Rivero A, Antonio Pineda J; Grupo Andaluz para el Estudio de las Hepatitis Víricas (HEPAVIR) de la Socied — View Citation

Merchante N, Rivero-Juárez A, Téllez F, Merino D, Ríos-Villegas MJ, Ojeda-Burgos G, Omar M, Macías J, Rivero A, Pérez-Pérez M, Raffo M, López-Montesinos I, Márquez-Solero M, Gómez-Vidal MA, Pineda JA; Grupo Andaluz para el Estudio de las Hepatitis Víricas — View Citation

Merchante N, Rivero-Juárez A, Téllez F, Merino D, Ríos-Villegas MJ, Villalobos M, Omar M, Rincón P, Rivero A, Pérez-Pérez M, Raffo M, López-Montesinos I, Palacios R, Gómez-Vidal MA, Macías J, Pineda JA; Members of the HEPAVIR-Cirrhosis Study Group. Sustai — View Citation

Merchante N, Saroli Palumbo C, Mazzola G, Pineda JA, Téllez F, Rivero-Juárez A, Ríos-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, Ma — View Citation

Merchante N, Téllez F, Rivero-Juárez A, Ríos-Villegas MJ, Merino D, Márquez-Solero M, Omar M, Recio E, Pérez-Pérez M, Camacho Á, Macías-Dorado S, Macías J, Lorenzo-Moncada S, Rivero A, Pineda JA; Grupo Andaluz para el Estudio de las Hepatitis Víricas (HEP — View Citation

Pineda JA, Recio E, Camacho A, Macías J, Almodóvar C, González-Serrano M, Merino D, Tellez F, Ríos MJ, Rivero A; Grupo Andaluz de Hepatitis Vírica (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Liver stiffness as a predictor of esop — View Citation

Recio E, Macías J, Rivero-Juárez A, Téllez F, Merino D, Ríos M, Márquez 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Liver-related mortality	Probability of liver-related death after enrollment	3 Years
Secondary	All cause mortality	Probability of death of any cause	3 Years