Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis

NCT ID: NCT07146529

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30060 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2036-09-30

Brief Summary

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.

Conditions

HIV Seropositivity; HIV Drug Resistance; HIV Infections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSERM UMR S 1136

OTHER

Sponsor Role: collaborator

iPLesp

UNKNOWN

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clara AVERLANT, Master's degree

Role: CONTACT

clara.averlant@iplesp.upmc.fr

07 64 45 38 49

Tounes SAIDI

Role: CONTACT

tounes.saidi@inserm.fr

+33 (0) 1 53 94 60 34

Other Identifiers

ANRS0789s PRINAVIH

Identifier Type: -

Identifier Source: org_study_id