Hepatocellular Carcinoma in HIV-infected Patients

HIV Clinical Trial

— GEHEP-002  

Official title:

Hepatocellular Carcinoma in HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785835
• Other study ID #: GEHEP-002
• Secondary ID: RIS-VAC12
• Status: Completed
• Start date: May 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2022
• Source: Hospital Universitario de Valme
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infection

• Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus
• Hepatitis C
• Hepatitis C, Chronic
• Hepatocellular Carcinoma
• HIV
• Liver Cirrhosis

Locations

Country	Name	City	State
Spain	Hospital Universitario A Coruña	A Coruna	La Coruña
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital German Trias i Pujol	Badalona	Barcelona
Spain	Hospital de San Eloy	Barakaldo	Vizcaya
Spain	Hospital de Basurto	Basurto	Vizcaya
Spain	Hospital de Cruces	Bilbao	Vizcaya
Spain	Hospital de Puerto Real	Cádiz
Spain	Hospital de Santa Lucía	Cartagena	Murcia
Spain	Hospital General de Castellón	Castellón De La Plana	Castellón
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital de Galdakao	Galdakao	Vizcaya
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Complejo Hospitalario de Huelva	Huelva
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital de La Linea	La Línea de la Concepción	Cádiz
Spain	Hospital de San Pedro	Logroño	La Rioja
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Regional Carlos Haya	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Universitario Arrixaca	Murcia
Spain	Hospital de Orihuela	Orihuela	Alicante
Spain	Hospital Universitario de Canarias	San Cristóbal de la Laguna	Santa Cruz De Tenerife
Spain	Hospital Clínico Universitario de San Juan	San Juan de Alicante	Alicante
Spain	Hospital Universitario de Donostia	San Sebastián	Guipúzcua
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Marina Baixa	Villajoyosa	Alicante
Spain	Hospital de Txagorritxu	Vitoria	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Valme

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Merchante N, Figueruela B, Rodríguez-Fernández M, Rodríguez-Arrondo F, Revollo B, Ibarra S, Galindo MJ, Merino E, Montero M, Téllez F, García-Deltoro M, Rivero-Juárez A, Delgado-Fernández M, Ríos-Villegas MJ, Aguirrebengoa K, García MA, Portu J, Vera-Ménd — View Citation

Merchante N, Ibarra S, Revollo B, Rodríguez-Arrondo F, Merino E, Delgado-Fernández M, Montero-Alonso M, Téllez F, Galindo MJ, Rivero-Juárez A, García MA, Mínguez C, Romero-Palacios A, Garcia-Deltoro M, Pineda JA; GEHEP-002 Study Group. Real-life experienc — View Citation

Merchante N, Merino E, López-Aldeguer J, Jover F, Delgado-Fernández M, Galindo MJ, Ortega E, Rivero A, Mínguez C, Romero-Palacios A, Padilla S, Márquez-Solero M, Amador C, Ríos-Villegas MJ, Téllez F, Portilla J, Pineda JA. Increasing incidence of hepatoce — View Citation

Merchante N, Merino E, Rodríguez-Arrondo F, Tural C, Muñoz J, Delgado-Fernández M, Jover F, Galindo MJ, Rivero A, López-Aldeguer J, Aguirrebengoa K, Romero-Palacios A, Martínez E, Pineda JA. HIV/hepatitis C virus-coinfected patients who achieved sustained — View Citation

Merchante N, Rodríguez-Arrondo F, Revollo B, Merino E, Ibarra S, Galindo MJ, Montero M, García-Deltoro M, Rivero-Juárez A, Téllez F, Delgado-Fernández M, Ríos-Villegas MJ, García MA, Vera-Méndez FJ, Ojeda-Burgos G, López-Ruz MA, Metola L, Omar M, Alemán-V — View Citation

Pinato DJ, Allara E, Chen TY, Trevisani F, Minguez B, Zoli M, Harris M, Dalla Pria A, Merchante N, Platt H, Jain M, Caturelli E, Kikuchi L, Pineda J, Nelson M, Farinati F, Rapaccini GL, Aytaman A, Yin M, Tan CK, Bower M, Giannini EG, Bräu N; Liver Cancer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival after HCC diagnosis at 1 year	At 1 year