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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: May 28, 2014
Last verified: May 2014
  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:


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: December 2014
Estimated Primary Completion Date: September 2014 (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:

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: May 28, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Valme University Hospital:
HIV
antiretroviral drugs
hepatitis C virus
hepatitis B virus
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
Anti-Infective Agents
Anti-Retroviral Agents
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Immunologic Deficiency Syndromes
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
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
Antiviral Agents

ClinicalTrials.gov processed this record on November 25, 2014