NCT02093754

Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients

Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will allow to assess liver related injuries in HIV patients.

Detailed description

This study is a cross-sectional, multicentre study including 7 centres from 3 European countries (Belgium, France, Germany). The maximum duration of the study for each patient will be 4 months, consisting of: * a screening visit, * an inclusion visit to perform the biologic tests and exams necessary for the study, within 1 month after the screening visit, * a result delivery visit within 1 month after inclusion visit, to disclose results of previous investigations. Patients with one or two non invasive markers suggesting significant fibrosis (≥F2) will be invited for liver biopsy within the next 2 months. * a "liver biopsy" visit, within 2 months after visit 2, liver biopsy in selected and consented patients

Conditions

• HIV Infection
• Liver Injuries

Interventions

Type	Name	Description
PROCEDURE	MRI and biopsy

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-03-21
• Last updated: 2016-07-12

Locations

7 sites across 3 countries: Belgium, France, Germany