HIV Clinical Trial
Official title:
Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients
Verified date | February 2021 |
Source | Hospital Universitario de Valme |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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: - |
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 |
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 |
Spain,
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
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 |
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