Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2014 by Valme University Hospital

Sponsor:

Collaborators:

Hospital Universitario Virgen de la Victoria

Hospital Universitario Reina Sofia

Hospital Torrecárdenas

Hospital de la Línea de la Concepción

Hospital Poniente

Virgen de la Macarena University Hospital

Complejo Hospitalario de Especialidades Juan Ramón Jimenez

Information provided by (Responsible Party):

Karin Neukam, Valme University Hospital

ClinicalTrials.gov Identifier:

NCT01908660

First received: June 28, 2013

Last updated: December 11, 2014

Last verified: May 2014

History of Changes

Purpose

The purpose of this study is to compare the liver toxicity in HIV-infected patients with chronic hepatitis B and/or hepatitis C, who start a new antiretroviral drug regimen, as well as the influence of the degree of pre-existing liver fibrosis on the incidence of liver toxicity.

Condition	Intervention
Human Immunodeficiency Virus Hepatitis B, Chronic Hepatitis C, Chronic	Drug: antiretroviral drugs


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration:	1 Year
Official Title:	Hepatic Safety of Currently Used Antiretroviral Regimens in HIV-infected Patients With Chronic Hepatitis B and/or Hepatitis C Under Real Life Conditions: The HEPAVIR HEPATIC SAFETY Cohort.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis B Hepatitis C

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Valme University Hospital:

Primary Outcome Measures:

Incidence of grade 3 or 4 transaminase elevations [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of grade 3 or 4 bilirubin elevations [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Percentage of patients with undetectable HIV RNA at the end of follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]
CD4 cell count at the end of follow-up [ Time Frame: one year ] [ Designated as safety issue: No ]


Estimated Enrollment:	500
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Antiretroviral drugs Pre-treated or treatment-naive HIV-infected patients with chronic hepatitis B and/or chronic hepatitis C who change an existing antiretroviral regimen or who start a new regimen.	Drug: antiretroviral drugs zidovudine lamivudine emtricitabine abacavir tenofovir nevirapine efavirenz etravirine rilpivirine lopinavir atazanavir fosamprenavir darunavir raltegravir maraviroc ritonavir

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients seen at the infectious disease unit of a terciary care center

Criteria

Inclusion Criteria:

Older than 18 years
HIV-1 infection as confirmed by ELISA and western blot
Chronic HCV infection as confirmed by HCV antibodies in plasma, as well as a positive HCV viral load determined by polymerase chain reaction OR chronic hepatitis B infection as confirmed by HBsAg
Treatment-naive or pretreated patients who start a new antiretroviral regimen that includes at least one drug that has not been received by the patient before
At least one week of exposure to new regimen
Liver biopsy or transient elastometry determination within 12 months prior to treatment initiation

Exclusion Criteria:

Pregnancy
Treatment against hepatitis C virus infection
Presence of opportunistic infections, including tuberculosis, neoplasia, autoimmune diseases. Patients receiving primary or secondary chemotherapy against an opportunistic process are not included.
Any liver disease of vascular, metabolic, biliary, autoimmune or tumoral origin
Patients who are not able to provide written informed consent to participate in the study
Lack of scheduled clinical visits including blood analysis throughout study period

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908660

Contacts


Contact: Karin I Neukam, PhD	0034955015871	karin.neukam@gmail.com
Contact: José A Mira-Escarti, MD	0034955015684	miraescarti@yahoo.es

Locations


Spain
Hospital Universitario de Valme	Recruiting
Seville, Spain, 41014
Contact: Karin I Neukam, PhD 0034955871 karin.neukam@gmail.com
Contact: José A Mira-Escarti, MD 0034955015684 miraescarti@yahoo.es
Principal Investigator: Karin I Neukam, PhD
Sub-Investigator: José A Mira-Escarti, MD
Sub-Investigator: Juan A Pineda-Vergara, MD, PhD
Sub-Investigator: Juan Macías-Sánchez, MD, PhD

Sponsors and Collaborators

Valme University Hospital

Hospital Universitario Virgen de la Victoria

Hospital Universitario Reina Sofia

Hospital Torrecárdenas

Hospital de la Línea de la Concepción

Hospital Poniente

Virgen de la Macarena University Hospital

Complejo Hospitalario de Especialidades Juan Ramón Jimenez

Investigators


Principal Investigator:	Karin I Neukam, PhD	Hospital Universitario de Valme

More Information

Publications:

Neukam K, Mira JA, Ruiz-Morales J, Rivero A, Collado A, Torres-Cornejo A, Merino D, de Los Santos-Gil I, Macías J, González-Serrano M, Camacho A, Parra-García G, Pineda JA; SEGURIDAD HEPÁTICA Study Team of the Grupo HEPAVIR de la Sociedad Andaluza de Enfermedades Infecciosas (SAEI). Liver toxicity associated with antiretroviral therapy including efavirenz or ritonavir-boosted protease inhibitors in a cohort of HIV/hepatitis C virus co-infected patients. J Antimicrob Chemother. 2011 Nov;66(11):2605-14. doi: 10.1093/jac/dkr357. Epub 2011 Sep 7.

van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, Cahn P, Lalloo UG, van der Westhuizen IP, Malan DR, Johnson MA, Santos BR, Mulcahy F, Wood R, Levi GC, Reboredo G, Squires K, Cassetti I, Petit D, Raffi F, Katlama C, Murphy RL, Horban A, Dam JP, Hassink E, van Leeuwen R, Robinson P, Wit FW, Lange JM; 2NN Study team. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet. 2004 Apr 17;363(9417):1253-63.

Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf.

Ortiz R, Dejesus E, Khanlou H, Voronin E, van Lunzen J, Andrade-Villanueva J, Fourie J, De Meyer S, De Pauw M, Lefebvre E, Vangeneugden T, Spinosa-Guzman S. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. 2008 Jul 31;22(12):1389-97. doi: 10.1097/QAD.0b013e32830285fb.

Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, Leavitt R, Nguyen BY. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012 Feb;13(2):127-31. doi: 10.1111/j.1468-1293.2011.00933.x. Epub 2011 May 22.

Pineda JA, Santos J, Rivero A, Abdel-Kader L, Palacios R, Camacho A, Lozano F, Macías J; Liverey Study Investigator Team. Liver toxicity of antiretroviral combinations including atazanavir/ritonavir in patients co-infected with HIV and hepatitis viruses: impact of pre-existing liver fibrosis. J Antimicrob Chemother. 2008 Apr;61(4):925-32. doi: 10.1093/jac/dkn045. Epub 2008 Feb 14.

Palacios R, Vergara S, Rivero A, Aguilar I, Macías J, Camacho A, Lozano F, García-Lázaro M, Pineda JA, Torre-Cisneros J, Márquez M, Santos J. Low incidence of severe liver events in HIV patients with and without hepatitis C or B coinfection receiving lopinavir/ritonavir. HIV Clin Trials. 2006 Nov-Dec;7(6):319-23.

Macías J, Neukam K, Portilla J, Iribarren JA, de Los Santos I, Rivero A, Márquez M, Delgado M, Téllez F, Merino D, Giner L, von Wichmann MA, Pineda JA; HEPRAL study team. Liver tolerance of raltegravir-containing antiretroviral therapy in HIV-infected patients with chronic hepatitis C. J Antimicrob Chemother. 2011 Jun;66(6):1346-50. doi: 10.1093/jac/dkr083. Epub 2011 Mar 10.

Aranzabal L, Casado JL, Moya J, Quereda C, Diz S, Moreno A, Moreno L, Antela A, Perez-Elias MJ, Dronda F, Marín A, Hernandez-Ranz F, Moreno A, Moreno S. Influence of liver fibrosis on highly active antiretroviral therapy-associated hepatotoxicity in patients with HIV and hepatitis C virus coinfection. Clin Infect Dis. 2005 Feb 15;40(4):588-93. Epub 2005 Jan 21.

Barreiro P, Rodríguez-Novoa S, Labarga P, Ruiz A, Jiménez-Nácher I, Martín-Carbonero L, Gonzalez-Lahoz J, Soriano V. Influence of liver fibrosis stage on plasma levels of antiretroviral drugs in HIV-infected patients with chronic hepatitis C. J Infect Dis. 2007 Apr 1;195(7):973-9. Epub 2007 Feb 20.


Responsible Party:	Karin Neukam, PhD, Valme University Hospital
ClinicalTrials.gov Identifier:	NCT01908660 History of Changes
Other Study ID Numbers:	SEG-HEP-2007
Study First Received:	June 28, 2013
Last Updated:	December 11, 2014
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Valme University Hospital:


HIV hepatitis C virus hepatitis B virus antiretroviral drugs nucleos(t)ide reverse transcriptase inhibitors non-nucleos(t)ide reverse transcriptase inhibitors protease inhibitors	integrase inhibitors entry inhibitors transaminase elevations alanine aminotransferase aspartate aminotransferase bilirubin elevations hepatic fibrosis

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis C Hepatitis C, Chronic DNA Virus Infections Digestive System Diseases Enterovirus Infections Flaviviridae Infections Hepadnaviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human	Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Liver Diseases Picornaviridae Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Reverse Transcriptase Inhibitors Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents

ClinicalTrials.gov processed this record on March 03, 2015

To Top