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

NCT07146529 | Not Yet Recruiting DMC

• 1 other identifier: ANRS0789s PRINAVIH
• Study Type: observational
• Target: 30,060
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Seropositivity; HIV Drug Resistance; HIV Infections

Keywords

Genotyping; HIV-1; HIV drug resistance; Transmitted resistance; Viral diversity; Transmission clusters; Primary infection

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

• Participant who objects to the use of their data ;
• Participant currently on antiretroviral treatment ;
• Participant subject to legal protection measures (safeguard of justice).

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• INSERM UMR S 1136: collaborator
• iPLesp: collaborator

MeSH Terms

Conditions

HIV Seropositivity; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 1, 2036
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share