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| Name | Class |
|---|---|
| INSERM UMR S 1136 | OTHER |
| iPLesp | UNKNOWN |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation | 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%. | At baseline (at the time of HIV diagnosis) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adult participants (male or female) aged 18 years or older, newly diagnosed with HIV-1 in participating laboratories where mandatory reporting to Santé Publique France (SPF) is required. Participants must be antiretroviral treatment-naïve (except for PrEP or PEP) and have an available HIV resistance genotype including amplification of at least reverse transcriptase and protease. Participants who have not objected to participation in the study are eligible. Excluded are participants currently on antiretroviral treatment, those who object to the use of their data, and individuals under legal protection measures (safeguard of justice)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara AVERLANT, Master's degree | Contact | 07 64 45 38 49 | clara.averlant@iplesp.upmc.fr | |
| Tounes SAIDI | Contact | +33 (0) 1 53 94 60 34 | tounes.saidi@inserm.fr |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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