Hepatocellular Carcinoma in HIV-infected Patients

NCT ID: NCT02785835

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

477 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma HIV Chronic Hepatitis C Hepatitis B Virus Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Valme

OTHER

Sponsor Role lead

Responsible Party

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Nicolás Merchante

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Orihuela

Orihuela, Alicante, Spain

Site Status

Hospital Clínico Universitario de San Juan

Sant Joan d'Alacant, Alicante, Spain

Site Status

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

Site Status

Hospital German Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital General de Castellón

Castellon, Castellón, Spain

Site Status

Hospital de La Linea

La Línea de la Concepción, Cádiz, Spain

Site Status

Hospital Universitario de Donostia

San Sebastián, Guipúzcua, Spain

Site Status

Hospital Universitario A Coruña

A Coruña, La Coruña, Spain

Site Status

Hospital de San Pedro

Logroño, La Rioja, Spain

Site Status

Hospital de Santa Lucía

Cartagena, Murcia, Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status

Hospital de San Eloy

Barakaldo, Vizcaya, Spain

Site Status

Hospital de Basurto

Basurto, Vizcaya, Spain

Site Status

Hospital de Cruces

Bilbao, Vizcaya, Spain

Site Status

Hospital de Galdakao

Galdakao, Vizcaya, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital de Puerto Real

Cadiz, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Complejo Hospitalario de Huelva

Huelva, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Hospital Universitario La Princesa

Madrid, , Spain

Site Status

Hospital Regional Carlos Haya

Málaga, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Universitario Arrixaca

Murcia, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Clínico de Valencia

Valencia, , Spain

Site Status

Hospital General de Valencia

Valencia, , Spain

Site Status

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Site Status

Hospital de Txagorritxu

Vitoria-Gasteiz, Álava, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 24056067 (View on PubMed)

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.

Reference Type RESULT
PMID: 22955438 (View on PubMed)

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.

Reference Type RESULT
PMID: 27755109 (View on PubMed)

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.

Reference Type RESULT
PMID: 29596108 (View on PubMed)

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.

Reference Type RESULT
PMID: 30562130 (View on PubMed)

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.

Reference Type RESULT
PMID: 30325782 (View on PubMed)

Other Identifiers

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RIS-VAC12

Identifier Type: OTHER

Identifier Source: secondary_id

GEHEP-002

Identifier Type: -

Identifier Source: org_study_id

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