Hepatocellular Carcinoma in HIV-infected Patients (GEHEP-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02785835
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):
Nicolás Merchante, Hospital Universitario de Valme

Brief 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.

Condition or disease
Hepatocellular Carcinoma HIV Chronic Hepatitis C Hepatitis B Virus Liver Cirrhosis

Study Type : Observational
Estimated Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Hepatocellular Carcinoma in HIV-infected Patients
Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Overall survival [ Time Frame: At 1 year ]
    Overall survival after HCC diagnosis at 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02785835

Contact: Nicolás Merchante, MD, PhD 955015684

Hospital de Orihuela Completed
Orihuela, Alicante, Spain
Hospital Clínico Universitario de San Juan Completed
San Juan de Alicante, Alicante, Spain
Hospital Marina Baixa Completed
Villajoyosa, Alicante, Spain
Hospital German Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Contact: Boris Revollo         
Principal Investigator: Boris Revollo         
Hospital de La Linea Recruiting
La Línea de la Concepción, Cádiz, Spain
Contact: Francisco Téllez         
Principal Investigator: Francisco Téllez         
Sub-Investigator: Monserrat Pérez-Pérez         
Hospital Universitario de Donostia Recruiting
San Sebastián, Guipúzcua, Spain
Contact: Francisco Rodríguez-Arrondo         
Principal Investigator: Francisco Rodríguez-Arrondo         
Hospital Universitario A Coruña Active, not recruiting
A Coruna, La Coruña, Spain
Hospital de San Pedro Recruiting
Logroño, La Rioja, Spain
Contact: Luis Metola         
Principal Investigator: Luis Metola         
Hospital de Santa Lucía Recruiting
Cartagena, Murcia, Spain
Contact: Francisco Jesús Vera Méndez         
Principal Investigator: Francisco Jesús Vera Méndez         
Hospital Universitario de Canarias Recruiting
San Cristóbal de la Laguna, Santa Cruz De Tenerife, Spain
Contact: Juan Luis Gómez-Sirvent         
Principal Investigator: Juan Luis Gómez-Sirvent         
Principal Investigator: Maria Remedios Alemán Valls         
Hospital de San Eloy Recruiting
Barakaldo, Vizcaya, Spain
Contact: Rafael Silvariño         
Principal Investigator: Rafael Silvariño         
Hospital de Basurto Recruiting
Basurto, Vizcaya, Spain
Contact: Sofia Ibarra Ugarte         
Principal Investigator: Sofia Ibarra Ugarte         
Hospital de Cruces Recruiting
Bilbao, Vizcaya, Spain
Contact: Koldo Aguirrebengoa         
Principal Investigator: Koldo Aguirrebengoa         
Hospital de Galdakao Recruiting
Galdakao, Vizcaya, Spain
Contact: Eduardo Martínez         
Principal Investigator: Eduardo Martínez         
Sub-Investigator: Maria Asunción García         
Hospital General Universitario de Alicante Recruiting
Alicante, Spain
Contact: Esperanza Merino         
Principal Investigator: Esperanza Merino         
Hospital General de Castellón Recruiting
Castellón, Spain
Contact: Carlos Mínguez         
Principal Investigator: Carlos Mínguez         
Hospital de Puerto Real Recruiting
Cádiz, Spain
Contact: Francisco Téllez         
Principal Investigator: Francisco Téllez         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Antonio Rivero         
Principal Investigator: Antonio Rivero         
Principal Investigator: Antonio Rivero-Juárez         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Miguel Angel López Ruz, MD         
Principal Investigator: Miguel Angel López Ruz         
Complejo Hospitalario de Huelva Recruiting
Huelva, Spain
Contact: Dolores Merino         
Principal Investigator: Dolores Merino         
Sub-Investigator: Miguel Raffo         
Complejo Hospitalario de Jaén Recruiting
Jaén, Spain
Contact: Mohamed Omar         
Principal Investigator: Mohamed Omar         
Sub-Investigator: Maria Amparo Gómez Vidal         
Hospital Universitario La Princesa Recruiting
Madrid, Spain
Contact: Ignacio de los Santos         
Principal Investigator: Ignacio de los Santos         
Hospital Universitario Arrixaca Recruiting
Murcia, Spain
Contact: Carlos Galera Peñaranda         
Principal Investigator: Carlos Galera Peñaranda         
Hospital Regional Carlos Haya Recruiting
Málaga, Spain
Contact: Marcial Delgado-Fernández         
Principal Investigator: Marcial Delgado-Fernández         
Hospital Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Rosario Palacios, MD         
Principal Investigator: Rosario Palacios         
Principal Investigator: Jesús Santos         
Sub-Investigator: Guillerno Ojeda Burgos         
Sub-Investigator: Marina Villalobos         
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41011
Contact: Maria J. Rios Villegas         
Principal Investigator: Maria J. Rios Villegas         
Hospital Clínico de Valencia Recruiting
Valencia, Spain
Contact: Maria José Galindo         
Principal Investigator: Maria José Galindo         
Hospital General de Valencia Recruiting
Valencia, Spain
Contact: Miguel García del Toro         
Principal Investigator: Miguel García Deltoro         
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain
Contact: José López-Aldeguer         
Principal Investigator: Jose López-Aldeguer         
Principal Investigator: Marta Montero-Alonso         
Hospital de Txagorritxu Recruiting
Vitoria, Álava, Spain
Contact: Joseba Portu         
Principal Investigator: Joseba Portu         
Sponsors and Collaborators
Hospital Universitario de Valme

Publications of Results:

Responsible Party: Nicolás Merchante, MD, PhD, Hospital Universitario de Valme Identifier: NCT02785835     History of Changes
Other Study ID Numbers: GEHEP-002
RIS-VAC12 ( Other Identifier: Instituto de Salud Carlos III )
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Carcinoma, Hepatocellular
Hepatitis, Chronic
Hepatitis B
Hepatitis C, Chronic
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections