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Study population A sample of 2000 HIV patients will be constructed, containing a discovery cohort and confirmation cohort. Sub-Sahara Africa's present study will also include HIV-infected patients with a more pronounced phenotype, females, and subjects originating from Sub-Sahara Africa. Relevant information from the medical centers and the HIV Monitoring Foundation will also be obtained. Liver Disease evaluation by liver ultrasound and FibroScan can be done by an alcoholic Fatty Liver Disease investigator. Using circulating white blood cells from venous blood, the immune system's function will be assessed at several levels. Relevant data from the patients' records and the HIV Monitoring Foundation will also be collected. Liver Disease diagnosis by liver ultrasound and FibroScan is a non-Alcoholic Fatty Liver Disease risk factor in liver ultrasound and FibroScan. Patients will always be seen first by a treating physician or specialized nurse, according to a patient informed consent procedure. Any questions the patient may have and planned for the first visit will be answered by the physician-researcher. Patient registry procedures The patient data will only be stored in encrypted form in a safe database with audit and editing trail is included. The patient information and study code is stored in a password-protected key file that is only accessible to the local research team, and is only accessible to the local research team. In the CASTOR questionnaires and eCRFs, the investigators will perform as many data checks as possible. Biomaterials The researchers will continue to and process in the Radboudumc laboratory in Nijmegen.
Source link: https://clinicaltrials.gov/ct2/show/NCT03994835
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