HIV Drug Resistance, HIV Infections, HIV Seropositivity
Conditions
Keywords
Genotyping, HIV-1, HIV drug resistance, Transmitted resistance, Viral diversity, Transmission clusters, Primary infection
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.
Interventions
None listed
Sponsors
INSERM UMR S 1136
iPLesp
ANRS, Emerging Infectious Diseases
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation | At baseline (at the time of HIV diagnosis) | Data will be collected once, at the time of HIV diagnosis. The participant's genotypic resistance test is performed locally and is part of the standard pre-therapeutic assessment. The presence of resistance mutations will be defined by the identification of at least one resistance mutation included in the Stanford and IAS resistance mutation lists. Antiretroviral resistance will be analyzed using the latest versions of the ANRS and Stanford algorithms. The χ² (chi-square) or Fisher exact test will be used to compare categorical variables and the Mann Whitney test will be used to compare continuous variables between groups. 95% confidence intervals will be constructed for each calculated proportion. Univariate and multivariate logistic regression models will be used to identify the factors associated with the detection of viruses resistant or possibly resistant to antiretrovirals. The statistical tests will be bilateral with a significance threshold set at 5%. |
Contacts
Primary ContactClara AVERLANT, Master's degree
Backup ContactTounes SAIDI
Outcome results
None listed