Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under… (NCT01908660) | Clinical Trial Compass
CompletedNot Applicable
Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life Conditions
Spain192 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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