Status:
COMPLETED
Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions
Lead Sponsor:
Valme University Hospital
Collaborating Sponsors:
Hospital Universitario Virgen de la Victoria
Hospital Universitario Reina Sofia de Cordoba
Conditions:
Human Immunodeficiency Virus
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
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 o...
Detailed Description
In the last years, various clinical trials and studies have evaluated the incidence of hepatic toxicity (HT) associated with the commonly used antiretroviral drugs in the HIV/hepatitis C virus (HCV)-i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01908660
Start Date
January 1 2007
End Date
October 1 2015
Last Update
November 11 2015
Active Locations (1)
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1
Hospital Universitario de Valme
Seville, Spain, 41014