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

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ClinicalTrials.gov Identifier: NCT01908660
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : November 11, 2015
Sponsor:
Collaborators:
Hospital Universitario Virgen de la Victoria
Hospital Universitario Reina Sofia de Cordoba
Hospital Torrecárdenas
Hospital de la Línea de la Concepción
Hospital Poniente
Hospital Universitario Virgen Macarena
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
Information provided by (Responsible Party):
Karin Neukam, Valme University Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Human Immunodeficiency Virus Hepatitis B, Chronic Hepatitis C, Chronic Drug: antiretroviral drugs

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Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 192 participants
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.
Study Start Date : January 2007
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of grade 3 or 4 transaminase elevations [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Incidence of grade 3 or 4 bilirubin elevations [ Time Frame: one year ]
  2. Percentage of patients with undetectable HIV RNA at the end of follow-up [ Time Frame: one year ]
  3. CD4 cell count at the end of follow-up [ Time Frame: one year ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908660


Locations
Spain
Hospital Universitario de Valme
Seville, Spain, 41014
Sponsors and Collaborators
Valme University Hospital
Hospital Universitario Virgen de la Victoria
Hospital Universitario Reina Sofia de Cordoba
Hospital Torrecárdenas
Hospital de la Línea de la Concepción
Hospital Poniente
Hospital Universitario Virgen Macarena
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
Investigators
Principal Investigator: Karin I Neukam, PhD Hospital Universitario de Valme
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Karin Neukam, PhD, Valme University Hospital
ClinicalTrials.gov Identifier: NCT01908660     History of Changes
Other Study ID Numbers: SEG-HEP-2007
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Karin Neukam, 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:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis C, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action