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Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions
This study has been completed.
Sponsor:
Valme University Hospital
Collaborators:
Hospital Universitario Virgen de la Victoria
Hospital Universitario Reina Sofia
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
ClinicalTrials.gov Identifier:
NCT01908660
First received: June 28, 2013
Last updated: November 10, 2015
Last verified: November 2015
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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 Karin Neukam, Valme University Hospital:
Primary Outcome Measures:
- Incidence of grade 3 or 4 transaminase elevations [ Time Frame: one year ]
Secondary Outcome Measures:
- Incidence of grade 3 or 4 bilirubin elevations [ Time Frame: one year ]
- Percentage of patients with undetectable HIV RNA at the end of follow-up [ Time Frame: one year ]
- CD4 cell count at the end of follow-up [ Time Frame: one year ]
| Enrollment: | 192 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2015 |
| 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 (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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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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
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: | November 10, 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 |
ClinicalTrials.gov processed this record on June 28, 2017