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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02353767
Eligibility Criteria:
Inclusion Criteria:
A. For all patients:
* \>18 years of age
* HIV-1 infection for a minimum of 5 years confirmed by Western Blot or ELISA
* Signed and full comprehension of informed consent
* Affiliation to Sécurité Sociale
B. Specific to Cases :
Presence of metabolic syndrome according to the International Diabetes Foundation (IDF)
C. Matched Criteria specific to controls :
* Same age ± 7 years
* Same duration of HIV-1 infection ± 3 years
* Same criterion of HIV-1 viral load (according to 3 thresholds: 50 - 500, 501 - 1000 or \> 1000 c/mL)
Exclusion Criteria:
* Chronic hepatitis B (HBs-Ag positive or isolated positive antiHBc-Ab with positive HBV-DNA)
* Chronic hepatitis C (positive antiHCV-Ab)
* Active IV or oral drug use and/or ongoing substitution therapy
* Other known chronic hepatitis : auto-immune hepatitis, primary or secondary biliary cirrhosis, hemochromatosis, Wilson disease, alpha 1 anti-trypsin deficit, primary or secondary sclerosing cholangitis, biliary obstruction, liver vascular disease associated with HIV infection, biliary or liver cancer
* CD4 \< 50/mm3
* Any current opportunistic infection
* Serious condition influencing vital status
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02353767
Study Brief:
Protocol Section:
NCT02353767