Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30,060
- 主要终点
- Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participant who objects to the use of their data ;
- •Participant currently on antiretroviral treatment ;
- •Participant subject to legal protection measures (safeguard of justice).
结局指标
主要结局
Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation
时间窗: 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%.
次要结局
未报告次要终点