Hepatocellular Carcinoma in HIV-infected Patients
GEHEP-002
2 other identifiers
observational
477
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMarch 16, 2022
March 1, 2022
7.2 years
May 25, 2016
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival after HCC diagnosis at 1 year
At 1 year
Eligibility Criteria
HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.
You may qualify if:
- HIV infection
- Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Hospital de Orihuela
Orihuela, Alicante, Spain
Hospital Clínico Universitario de San Juan
Sant Joan d'Alacant, Alicante, Spain
Hospital Marina Baixa
Villajoyosa, Alicante, Spain
Hospital German Trias i Pujol
Badalona, Barcelona, Spain
Hospital General de Castellón
Castellon, Castellón, Spain
Hospital de La Linea
La Línea de la Concepción, Cádiz, Spain
Hospital Universitario de Donostia
San Sebastián, Guipúzcua, Spain
Hospital Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital de San Pedro
Logroño, La Rioja, Spain
Hospital de Santa Lucía
Cartagena, Murcia, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital de San Eloy
Barakaldo, Vizcaya, Spain
Hospital de Basurto
Basurto, Vizcaya, Spain
Hospital de Cruces
Bilbao, Vizcaya, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital de Puerto Real
Cadiz, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Complejo Hospitalario de Huelva
Huelva, Spain
Complejo Hospitalario de Jaén
Jaén, 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 Universitario Virgen Macarena
Seville, 41011, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Álava, Spain
Related Publications (6)
Merchante N, Merino E, Rodriguez-Arrondo F, Tural C, Munoz J, Delgado-Fernandez M, Jover F, Galindo MJ, Rivero A, Lopez-Aldeguer J, Aguirrebengoa K, Romero-Palacios A, Martinez E, Pineda JA. HIV/hepatitis C virus-coinfected patients who achieved sustained virological response are still at risk of developing hepatocellular carcinoma. AIDS. 2014 Jan 2;28(1):41-7. doi: 10.1097/QAD.0000000000000005.
PMID: 24056067RESULTMerchante N, Merino E, Lopez-Aldeguer J, Jover F, Delgado-Fernandez M, Galindo MJ, Ortega E, Rivero A, Minguez C, Romero-Palacios A, Padilla S, Marquez-Solero M, Amador C, Rios-Villegas MJ, Tellez F, Portilla J, Pineda JA. Increasing incidence of hepatocellular carcinoma in HIV-infected patients in Spain. Clin Infect Dis. 2013 Jan;56(1):143-50. doi: 10.1093/cid/cis777. Epub 2012 Sep 5.
PMID: 22955438RESULTMerchante N, Ibarra S, Revollo B, Rodriguez-Arrondo F, Merino E, Delgado-Fernandez M, Montero-Alonso M, Tellez F, Galindo MJ, Rivero-Juarez A, Garcia MA, Minguez C, Romero-Palacios A, Garcia-Deltoro M, Pineda JA; GEHEP-002 Study Group. Real-life experience with sorafenib for the treatment of hepatocellular carcinoma in HIV-infected patients. AIDS. 2017 Jan 2;31(1):89-95. doi: 10.1097/QAD.0000000000001293.
PMID: 27755109RESULTMerchante N, Rodriguez-Arrondo F, Revollo B, Merino E, Ibarra S, Galindo MJ, Montero M, Garcia-Deltoro M, Rivero-Juarez A, Tellez F, Delgado-Fernandez M, Rios-Villegas MJ, Garcia MA, Vera-Mendez FJ, Ojeda-Burgos G, Lopez-Ruz MA, Metola L, Omar M, Aleman-Valls MR, Aguirrebengoa K, Portu J, Raffo M, Macias J, Pineda JA; GEHEP-002 Study Group. Hepatocellular carcinoma after sustained virological response with interferon-free regimens in HIV/hepatitis C virus-coinfected patients. AIDS. 2018 Jul 17;32(11):1423-1430. doi: 10.1097/QAD.0000000000001809.
PMID: 29596108RESULTPinato 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, Brau N; Liver Cancer in HIV and ITA.LI.CA Study Groups. Influence of HIV Infection on the Natural History of Hepatocellular Carcinoma: Results From a Global Multicohort Study. J Clin Oncol. 2019 Feb 1;37(4):296-304. doi: 10.1200/JCO.18.00885. Epub 2018 Dec 18.
PMID: 30562130RESULTMerchante N, Figueruela B, Rodriguez-Fernandez M, Rodriguez-Arrondo F, Revollo B, Ibarra S, Galindo MJ, Merino E, Montero M, Tellez F, Garcia-Deltoro M, Rivero-Juarez A, Delgado-Fernandez M, Rios-Villegas MJ, Aguirrebengoa K, Garcia MA, Portu J, Vera-Mendez FJ, Villalobos M, Minguez C, De Los Santos I, Lopez-Ruz MA, Omar M, Galera C, Macias J, Pineda JA; GEHEP-002 Study Group. Low performance of ultrasound surveillance for the diagnosis of hepatocellular carcinoma in HIV-infected patients. AIDS. 2019 Feb 1;33(2):269-278. doi: 10.1097/QAD.0000000000002065.
PMID: 30325782RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 25, 2016
First Posted
May 30, 2016
Study Start
May 1, 2014
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
March 16, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share