ANRS 0788s MULTIVIR2025

Study type

Multivir2025 is a Category 3 non-interventional study involving human subjects, in accordance with the Jardé Act.

This is a cross-sectional, national, multicentre study involving retrospective and prospective data collection from all patients treated with antiretrovirals who have two consecutive viral loads (spaced at least two weeks and no more than twelve months apart) exceeding 50 copies/ml. The second viral load must be measured during the inclusion period.

An analysis of the virus’s resistance to antiretrovirals will be carried out, using a blood sample already taken during a viral load test performed at a follow-up visit. As part of this study, the results of this test will be used and certain data will be collected.

Study objectives

The main objective of the study is to determine, in a population of people living with HIV (PLHIV) experiencing virological failure, the proportion of participants carrying a virus that is resistant or possibly resistant to at least one antiretroviral from four different therapeutic classes: nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and integrase inhibitors (INIs).

Inclusion criteria

The primary endpoint is the proportion of patients harbouring multidrug-resistant viruses, i.e. those with resistance mutations to at least four classes of ARVs (NRTIs, NNRTs, PIs and INIs).

• Patients (male or female) aged 18 years or older.
• Patients who have been on antiretroviral therapy for at least six months, and whose plasma viral load (VL) is greater than 50 copies/ml on at least two consecutive measurements (spaced at least two weeks apart and less than 12 months apart), with these two viral load measurements having been performed in two separate laboratories.
• Patients who have given their informed consent to participate in the study.