Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV Seropositivity, HIV Drug Resistance, HIV Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The primary objective of the study is to determine the frequency of transmission of viruses carrying at least one antiretroviral resistance mutation in all participants newly diagnosed with HIV-1
Detailed description
This is a national, multicenter, cross-sectional study with both retrospective and prospective data collection :
Retrospective phase (2019-2024): Data will be collected from all participants diagnosed at the time of primary HIV-1 infection during these six years.
Prospective phase (2025-2035): Data will be collected from all participants newly diagnosed with HIV-1, regardless of whether they are at the stage of primary infection.
The study will be offered to all virology laboratories that participated in the last quality control of genotyping of the resistance group of the ANRS MIE virology laboratory network.
For ten years, the virology laboratories that participated in the last quality control of HIV resistance genotyping of the ANRS MIE Virology network will be asked to systematically include all patients meeting the inclusion criteria. The virology laboratories must send the list of eligible patients to the associated clinical centers, according to their usual data transfer procedure, so that they can inform the participants and obtain their consent. An information form will then be distributed to the participant.
Primary outcome measures
- Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation [Time frame: At baseline (at the time of HIV diagnosis)]
Eligibility criteria
Inclusion criteria
- Participant (male or female) aged 18 years or older ;
- Participant newly diagnosed in the laboratory, for whom mandatory HIV seropositivity reporting to Santé Publique France (SPF) is required ;
- Participant naïve to all antiretroviral treatments (except PrEP and/or post-exposure prophylaxis \[PEP\]) ;
- Participant with an available HIV resistance genotype, including amplification of at least reverse transcriptase and protease ;
- Participant who has not objected to participating in the study.
Exclusion criteria
- Participant who objects to the use of their data ;
- Participant currently on antiretroviral treatment ;
- Participant subject to legal protection measures (safeguard of justice).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07146529 · ANRS0789s PRINAVIH