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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ;

Disqualifiers

Participant who objects to the use of their data ;

Participant currently on antiretroviral treatment ;

Participant subject to legal protection measures (safeguard of justice).

Trial 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)

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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%.

Time frame
At baseline (at the time of HIV diagnosis)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

INSERM UMR S 1136

Collaborator

iPLesp

Collaborator

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