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
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Condition or disease | Intervention/treatment |
---|---|
Human Immunodeficiency Virus Hepatitis B, Chronic Hepatitis C, Chronic | Drug: antiretroviral drugs |

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 |
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.
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Drug: antiretroviral drugs
zidovudine lamivudine emtricitabine abacavir tenofovir nevirapine efavirenz etravirine rilpivirine lopinavir atazanavir fosamprenavir darunavir raltegravir maraviroc ritonavir
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- Incidence of grade 3 or 4 transaminase elevations [ Time Frame: one year ]
- 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 ]

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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 |
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

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
Spain | |
Hospital Universitario de Valme | |
Seville, Spain, 41014 |
Principal Investigator: | Karin I Neukam, PhD | Hospital Universitario de Valme |
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 |