Clinical trial NCT02785835: Hepatocellular Carcinoma in HIV-infected Patients
Official title: Hepatocellular Carcinoma in HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
HIV
Chronic Hepatitis C
Hepatitis B Virus
Liver Cirrhosis
Lead sponsor: Hospital Universitario de Valme
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: At 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital de Orihuela
state: Alicante
city: San Juan de Alicante
country: Spain
facility: Hospital Clínico Universitario de San Juan
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol
state: Barcelona
city: Castellón De La Plana
country: Spain
facility: Hospital General de Castellón
state: Castellón
city: La Línea de la Concepción
country: Spain
facility: Hospital de La Linea
state: Cádiz
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
state: Guipúzcua
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruña
state: La Coruña
city: Logroño
country: Spain
facility: Hospital de San Pedro
state: La Rioja
city: Cartagena
country: Spain
facility: Hospital de Santa Lucía
state: Murcia
city: San Cristóbal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Barakaldo
country: Spain
facility: Hospital de San Eloy
state: Vizcaya
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Cádiz
country: Spain
facility: Hospital de Puerto Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Complejo Hospitalario de Huelva
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Murcia
country: Spain
facility: Hospital Universitario Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Carlos Haya
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: Álava
Study officials:
References:
citation: 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.
citation: Merchante 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.
citation: Merchante 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.
citation: Merchante 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.
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, 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.
citation: Merchante 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.