HIV InfectionMULTIVIR2025NCT06842706
Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure. (MULTIVIR2025)
An observational study of HIV Infection, run by ANRS, Emerging Infectious Diseases.
Trial summary
In this cross-sectional, national and multicenter study, the main objective is to determine the prevalence of multi-drug resistant viruses (i.e., viruses that are resistant or possibly resistant to at least one antiretroviral drug from four different therapeutic classes: NRTI, NNRTI, PI, INSTI) among people with HIV 1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Mar 2026
- 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: Population of people living with HIV (PLHIV) in virological failure, the proportion of participants with virus resistant or possibly resistant to at least one antiretroviral agent from 4 different therapeutic classes: nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse trancriptase inhibitor (NNRTI), protease inhibitor (PI) and integrase inhibitor (INSTI).
Who may be able to join
- Patient (male or female) 18 years of age or older.
- Patient who has given his or her consent to participate in the study.
- Patient on antiretroviral therapy for at least six months, with a plasma viral load (VL) greater than 50 copies/mL on at least two consecutive measurements.
Who cannot join
- Patients opposed to the use of their data.
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
Official title: Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure.(MULTIVIR2025)
In this cross-sectional, national and multicenter study, the main objective is to determine the prevalence of multi-drug resistant viruses (i.e., viruses that are resistant or possibly resistant to at least one antiretroviral drug from four different therapeutic classes: NRTI, NNRTI, PI, INSTI) among people with HIV 1 (PWH) experiencing virological failure.
Read the detailed description
Detailed Description:
This is a cross-sectional, national and multicenter study with retrospective and prospective data collection. The study will be conducted in all French virology laboratories that participated in the last quality control for HIV genotypic resistance testing conducted by the ANRS MIE network (n = 42).
Study population All patients treated with antiretrovirals and experiencing virological failure (defined as two consecutive viral loads, at least two weeks apart, greater than 50 copies/mL) can be included in this study.
The study will run for twelve months, with a planned start in 2025. During six months, virologists will be asked to identify all patients meeting the inclusion criteria until they reach 20 patients (for centers following less than 2000 PLWHA) or 40 patients (for centers following more than 2000 PLWHA). Genotypic resistance testing will be performed for all these patients, as recommended by French guidelines. Genotypic resistance testing will always include the amplification of the reverse transcriptase (RT), protease (PR) and integrase (INT), whereas the amplification of gp120, gp41 and/or capsid will only be performed in patients receiving maraviroc, enfuvirtide or lenacapavir, respectively.
Genotypic resistance testing will be performed in each local laboratory, using Sanger or high-throughput sequencing.
Sample size It is estimated that the proportion of patients with multi-drug resistant viruses is between 1 and 5% in this population. Thus, the aim is to include at least 500 patients, which would allow to determine the proportion of multi-drug resistant viruses with an accuracy of 1 to 2%.
With at least 30 participating centers, an expected number of 800 patients should be included. Given the threshold used to define virological failure (50 copies/mL), it is expected that genotypic resistance testing will not be successful in a number of cases. Assuming that all patients with virological failure have viral loads between 51 and 200 copies/mL, and that the success rate for genotypic resistance testing is 63%, the number of patients for whom we would have genotypic data would be 504.
Data collection The virology laboratories will send the list of eligible patients to the associated clinical centers, according to their usual data transfer procedure, so that clinicians can inform the participants and obtain their informed consent. An information form will also be distributed to participants.
A unique identification code will be assigned to each patient that have agreed to this study. An electronic case report form will be used to collect genotypic, clinical and demographic data.
Data analysis Identification of drug resistance-associated mutations will be performed using two different algorithms: Stanford HIVDB (version 9.7, November 2024) and HIV French Resistance (version 35, April 2024).
- Conditions
- HIV Infection
- Keywords
- HIV, drug resistance, antiretrovirals, multi-drug resistant, virological failure
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug resistance-associated mutations are those defined in the current ANRS algorithm (https://hivfrenchresistance.org/hiv-french-resitance-tables-of-rules/) and in the current Stanford algorithm (http://hivdb.stanford.edu) at the time of analysis.
Genotypic resistance to an antiretroviral drug will be interpreted using these two algorithms. Resistance to a therapeutic class will be defined as a resistance, or possible resistance, to all drugs in the class.
Measured: Recruitment period: 6 months ·Participation period per participant: 1 day (no follow-up visit) ·Total research period: 12 months · Provisional start date: April 1, 2025 · Provisional end da
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Quentin Le Hingrat, DR, Principal investigator, Bichat-Claude Bernard University Hospital, Paris, AP-HP.NordConstance Delaugerre, PR, Principal investigator, Service de Virologie Hôpital Saint-Louis, AP-HP.Nord 1 avenue Claude Vellefaux, 75010 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842706
- Sponsor's protocol ID
- ANRS0788s MULTIVIR2025
- Acronym
- MULTIVIR2025
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 26 Feb 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure.(MULTIVIR2025)
- ClinicalTrials.gov ID
- NCT06842706
- Acronym / sponsor ID
- MULTIVIR2025 / ANRS0788s MULTIVIR2025
- Conditions
- HIV Infection
- Keywords
- HIV, drug resistance, antiretrovirals, multi-drug resistant, virological failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Feb 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.
In this cross-sectional, national and multicenter study, the main objective is to determine the prevalence of multi-drug resistant viruses (i.e., viruses that are resistant or possibly resistant to at least one antiretroviral drug from four different therapeutic classes: NRTI, NNRTI, PI, INSTI) among people with HIV 1 (PWH) experiencing virological failure.
Detailed description
Detailed Description:
This is a cross-sectional, national and multicenter study with retrospective and prospective data collection. The study will be conducted in all French virology laboratories that participated in the last quality control for HIV genotypic resistance testing conducted by the ANRS MIE network (n = 42).
Study population All patients treated with antiretrovirals and experiencing virological failure (defined as two consecutive viral loads, at least two weeks apart, greater than 50 copies/mL) can be included in this study.
The study will run for twelve months, with a planned start in 2025. During six months, virologists will be asked to identify all patients meeting the inclusion criteria until they reach 20 patients (for centers following less than 2000 PLWHA) or 40 patients (for centers following more than 2000 PLWHA). Genotypic resistance testing will be performed for all these patients, as recommended by French guidelines. Genotypic resistance testing will always include the amplification of the reverse transcriptase (RT), protease (PR) and integrase (INT), whereas the amplification of gp120, gp41 and/or capsid will only be performed in patients receiving maraviroc, enfuvirtide or lenacapavir, respectively.
Genotypic resistance testing will be performed in each local laboratory, using Sanger or high-throughput sequencing.
Sample size It is estimated that the proportion of patients with multi-drug resistant viruses is between 1 and 5% in this population. Thus, the aim is to include at least 500 patients, which would allow to determine the proportion of multi-drug resistant viruses with an accuracy of 1 to 2%.
With at least 30 participating centers, an expected number of 800 patients should be included. Given the threshold used to define virological failure (50 copies/mL), it is expected that genotypic resistance testing will not be successful in a number of cases. Assuming that all patients with virological failure have viral loads between 51 and 200 copies/mL, and that the success rate for genotypic resistance testing is 63%, the number of patients for whom we would have genotypic data would be 504.
Data collection The virology laboratories will send the list of eligible patients to the associated clinical centers, according to their usual data transfer procedure, so that clinicians can inform the participants and obtain their informed consent. An information form will also be distributed to participants.
A unique identification code will be assigned to each patient that have agreed to this study. An electronic case report form will be used to collect genotypic, clinical and demographic data.
Data analysis Identification of drug resistance-associated mutations will be performed using two different algorithms: Stanford HIVDB (version 9.7, November 2024) and HIV French Resistance (version 35, April 2024).
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
- Population of people living with HIV (PLHIV) in virological failure, the proportion of participants with virus resistant or possibly resistant to at least one antiretroviral agent from 4 different therapeutic classes: nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse trancriptase inhibitor (NNRTI), protease inhibitor (PI) and integrase inhibitor (INSTI).
Key inclusion criteria (3 listed)
- Patient (male or female) 18 years of age or older.
- Patient who has given his or her consent to participate in the study.
- Patient on antiretroviral therapy for at least six months, with a plasma viral load (VL) greater than 50 copies/mL on at least two consecutive measurements.
Key exclusion criteria (1 listed)
- Patients opposed to the use of their data.
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
Drug resistance-associated mutations are those defined in the current ANRS algorithm (https://hivfrenchresistance.org/hiv-french-resitance-tables-of-rules/) and in the current Stanford algorithm (http://hivdb.stanford.edu) at the time of analysis.
Time frame: Recruitment period: 6 months ·Participation period per participant: 1 day (no follow-up visit) ·Total research period: 12 months · Provisional start date: April 1, 2025 · Provisional end da
Genotypic resistance to an antiretroviral drug will be interpreted using these two algorithms. Resistance to a therapeutic class will be defined as a resistance, or possible resistance, to all drugs in the class.
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 26 Feb 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.
Quentin Le Hingrat, DR principal investigator
Bichat-Claude Bernard University Hospital, Paris, AP-HP.Nord
Constance Delaugerre, PR principal investigator
Service de Virologie Hôpital Saint-Louis, AP-HP.Nord 1 avenue Claude Vellefaux, 75010 Paris
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, 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 3 inclusion and 1 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 26 Feb 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 Mariam GHARIB (0144236442, mariam.gharib@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug resistance-associated mutations are those defined in the current ANRS algorithm (https://hivfrenchresistance.org/hiv-french-resitance-tables-of-rules/) and in the current Stanford algorithm (http://hivdb.stanford.edu) at the time of analysis. (time frame: Recruitment period: 6 months ·Participation period per participant: 1 day (no follow-up visit) ·Total research period: 12 months · Provisional start date: April 1, 2025 · Provisional end da). 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 26 Feb 2025.