HIV SeropositivityPRINAVIHNCT07146529
Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis
An observational study of HIV Seropositivity and HIV Drug Resistance, run by ANRS, Emerging Infectious Diseases.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity, HIV Drug Resistance, HIV Infections
- How many people
- 30,060 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2036
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Participant who objects to the use of their data ;
- Participant currently on antiretroviral treatment ;
- Participant subject to legal protection measures (safeguard of justice).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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.
- Conditions
- HIV Seropositivity, HIV Drug Resistance, HIV Infections
- Keywords
- Genotyping, HIV-1, HIV drug resistance, Transmitted resistance, Viral diversity, Transmission clusters, Primary infection
- Medical subject headings
- HIV Seropositivity, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At baseline (at the time of HIV diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2036 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30,060 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- INSERM UMR S 1136, iPLesp
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146529
- Sponsor's protocol ID
- ANRS0789s PRINAVIH
- Acronym
- PRINAVIH
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Transmitted HIV-1 Resistance, Viral Diversity, and Cluster Identification in Patients at the Time of HIV-1 Diagnosis
- ClinicalTrials.gov ID
- NCT07146529
- Acronym / sponsor ID
- PRINAVIH / ANRS0789s PRINAVIH
- Conditions
- HIV Seropositivity, HIV Drug Resistance, HIV Infections
- Keywords
- Genotyping, HIV-1, HIV drug resistance, Transmitted resistance, Viral diversity, Transmission clusters, Primary infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30,060 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- INSERM UMR S 1136, iPLesp
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Sep 2036 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Participant who objects to the use of their data ;
- Participant currently on antiretroviral treatment ;
- Participant subject to legal protection measures (safeguard of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation
Time frame: 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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and HIV Drug Resistance, run by ANRS, Emerging Infectious Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara AVERLANT, Master's degree (07 64 45 38 49, clara.averlant@iplesp.upmc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of treatment-naïve or acutely infected participants with a virus carrying at least one antiretroviral resistance mutation (time frame: At baseline (at the time of HIV diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.