Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01908660
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01908660
Study Brief:
Protocol Section:
NCT01908660