HIV-1PRECARITYNCT07122557
Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France -IMEA073
An observational study of HIV-1 and Public Universal Healthcare Insurance Coverage, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
Trial summary
In France, French citizens with an annual income less than 10339 euros are considered living with low-income and are eligible to benefit from a public universal healthcare insurance coverage called C2S (complémentaire santé solidaire). C2S covers primary care and hospital care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1, Public Universal Healthcare Insurance Coverage, BIC/FTC/TAF
- What is being tested?
- Biktarvy
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2025
- 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: Treatment naïve (TN) and Virologically Suppressed Treatment Experienced (VS TE) in 2d line treatment, or Virologically Unsuppressed Treatment Experienced (VU TE) in 2d line treatment patients within Paris Bichat and CHU Nantes hospitals who were covered by C2S/AME heath insurance during study period. - Those using BIC/FTC/TAF We will conduct descriptive analyses only. Analyses will be disaggregated by TN, VS TE, and VU TE groups.
Who may be able to join
- HIV-1 infected patients > 18 years during the observation period
- PLWH with C2S or AME heath insurance coverage information available during the observation period
- Treatment naive (TN) on BIC/FTC/TAF OR Treatment experienced virologically suppressed (VS TE) or virologically unsupressed (VU TE) in 2d line BIC/FTC/TAF
- Had at least one follow-up visit after baseline
Who cannot join
- Missing information regarding health insurance coverage
- On regimen other than BIC/FTC/TAF
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aïda BENALYCHERIF contact
About this study
Official title: Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France
In France, French citizens with an annual income less than 10339 euros are considered living with low-income and are eligible to benefit from a public universal healthcare insurance coverage called C2S (complémentaire santé solidaire). C2S covers primary care and hospital care. Non-citizens with low income, like some migrants, can also benefit from a public healthcare insurance coverage called AME ("Aide Medicale d'Etat" for State Medical Aid). These criteria are used as a marker of precarity settings (i.e., socio-economic vulnerability) in France. In France, HIV-related care and treatments are reimbursed at 100% (ALD30), whatever the level of precariousness. ART adherence has been shown significantly lower in PLWH with C2S health insurance coverage. Although BIC/FTC/TAF is a recommended preferred option in naive PLWH and in switch or maintenance therapy in most settings, due to the forgiveness profile and the high genetic barrier to resistance, boosted darunavir (DRV/r) remains even more widely used than 2nd generation InSTIs in populations in precarity settings, and Real World Effectiveness (RWE) with BIC/FTC/TAF is missing to better support its use in these settings.
Paris Bichat Hospital (located in one of the poorest districts in the Ile-de-France region) and Nantes university hospital (West France region) follow a cohort of PLWH with a high proportion of populations in precarity settings (i.e with C2S and AME health insurance coverage): Paris Bichat hospital: N=5143 PLWH (December 2021), sex ratio F/M 37/56%, Transgender Women 7%, and born in sub-Saharan African countries 49%. Nantes university hospital: N=2227 PLWH (December 2021), sex ratio F/M 35/65% and born in sub-Saharan African countries 33%. In this cohort of 7370 PLWH in both sites 50% are receiving an InSTI-based ART regimen, regardless of prior treatment history, and at least 40% are receiving care through the C2S or AME, respectively.
- Being tested
- Biktarvy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiktarvyDrug
this study applies secondary use of data collected from medical health records
| Study group | Role | What they receive |
|---|---|---|
| Treatment naive,virologically suppressed and unsuppressed treatment experienced in 2nd line | Not described Receives: Drug: Biktarvy |
What is being measured
The primary outcome is the main question the study is designed to answer.
i. HIV RNA ≥50 copies/mL at week 48 within the time window OR One HIV RNA ≥50 copies/mL followed by treatment discontinuation before week 48 after reaching HIV RNA < 50 copies/mL
Measured: Week 48
ii. Discontinuation due to treatment related adverse event
Measured: week 48
iii. Discontinuation due to non-treatment related adverse event, death or other reasons
Measured: week 48
iv. On study but missing data in window
Measured: Week 48+/- 8 weeks
i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL
Measured: week 48
ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL
Measured: week 48
iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation
Measured: week 48
Secondary outcomes (10)
• Evaluate the time to treatment discontinuation and reason for discontinuation with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.
Measured: week 48
• Describe subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE.
Measured: week 48
• Describe the number of hospital medical HIV appointments, and participants baseline characteristics with BIC/FTC/TAF among TN, VS TE and VU TE PLWH
Measured: week 48
• Describe treatment emergent resistance profile among participants with confirmed virologic failure with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.
Measured: week 48
• Describe the change of CD4
CD4 description
Measured: week 48
• Factors associated with virologic suppression (HIV RNA<50 copies/mL, FDA Snapshot), confirmed virologic failure (HIV RNA ≥200 copies/mL), discontinuation, and emergence of resistance-associated mutations at failure among TN, VS TE and VU TE.
Measured: week 48
• Describe the change of CD8 cell counts
CD8 description
Measured: Week 48
• Describe the change CD4/CD8 ratio
description CD4/CD8 ratio
Measured: Week 48
• Describe the change of BMI
BMI description
Measured: Week 48
• Describe the change of body weight
Body weight description
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland LANDMAN, Principal investigator, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122557
- Sponsor's protocol ID
- IMEA
- Acronym
- PRECARITY
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France
- ClinicalTrials.gov ID
- NCT07122557
- Acronym / sponsor ID
- PRECARITY / IMEA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 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.
In France, French citizens with an annual income less than 10339 euros are considered living with low-income and are eligible to benefit from a public universal healthcare insurance coverage called C2S (complémentaire santé solidaire). C2S covers primary care and hospital care. Non-citizens with low income, like some migrants, can also benefit from a public healthcare insurance coverage called AME ("Aide Medicale d'Etat" for State Medical Aid). These criteria are used as a marker of precarity settings (i.e., socio-economic vulnerability) in France. In France, HIV-related care and treatments are reimbursed at 100% (ALD30), whatever the level of precariousness. ART adherence has been shown significantly lower in PLWH with C2S health insurance coverage. Although BIC/FTC/TAF is a recommended preferred option in naive PLWH and in switch or maintenance therapy in most settings, due to the forgiveness profile and the high genetic barrier to resistance, boosted darunavir (DRV/r) remains even more widely used than 2nd generation InSTIs in populations in precarity settings, and Real World Effectiveness (RWE) with BIC/FTC/TAF is missing to better support its use in these settings.
Paris Bichat Hospital (located in one of the poorest districts in the Ile-de-France region) and Nantes university hospital (West France region) follow a cohort of PLWH with a high proportion of populations in precarity settings (i.e with C2S and AME health insurance coverage): Paris Bichat hospital: N=5143 PLWH (December 2021), sex ratio F/M 37/56%, Transgender Women 7%, and born in sub-Saharan African countries 49%. Nantes university hospital: N=2227 PLWH (December 2021), sex ratio F/M 35/65% and born in sub-Saharan African countries 33%. In this cohort of 7370 PLWH in both sites 50% are receiving an InSTI-based ART regimen, regardless of prior treatment history, and at least 40% are receiving care through the C2S or AME, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment naive,virologically suppressed and unsuppressed treatment experienced in 2nd line | – | Drug: Biktarvy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naïve (TN) and Virologically Suppressed Treatment Experienced (VS TE) in 2d line treatment, or Virologically Unsuppressed Treatment Experienced (VU TE) in 2d line treatment patients within Paris Bichat and CHU Nantes hospitals who were covered by C2S/AME heath insurance during study period. - Those using BIC/FTC/TAF We will conduct descriptive analyses only. Analyses will be disaggregated by TN, VS TE, and VU TE groups.
Key inclusion criteria (4 listed)
- HIV-1 infected patients > 18 years during the observation period
- PLWH with C2S or AME heath insurance coverage information available during the observation period
- Treatment naive (TN) on BIC/FTC/TAF OR Treatment experienced virologically suppressed (VS TE) or virologically unsupressed (VU TE) in 2d line BIC/FTC/TAF
- Had at least one follow-up visit after baseline
Key exclusion criteria (2 listed)
- Missing information regarding health insurance coverage
- On regimen other than BIC/FTC/TAF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biktarvythis study applies secondary use of data collected from medical health records | Drug | Treatment naive,virologically suppressed and unsuppressed treatment experienced in 2nd line |
Primary outcome
i. HIV RNA ≥50 copies/mL at week 48 within the time window OR One HIV RNA ≥50 copies/mL followed by treatment discontinuation before week 48 after reaching HIV RNA < 50 copies/mL
Time frame: Week 48
ii. Discontinuation due to treatment related adverse event
Time frame: week 48
iii. Discontinuation due to non-treatment related adverse event, death or other reasons
Time frame: week 48
iv. On study but missing data in window
Time frame: Week 48+/- 8 weeks
i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL
Time frame: week 48
ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL
Time frame: week 48
iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation
Time frame: week 48
10 secondary outcomes
• Evaluate the time to treatment discontinuation and reason for discontinuation with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.
Time frame: week 48
• Describe subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE.
Time frame: week 48
• Describe the number of hospital medical HIV appointments, and participants baseline characteristics with BIC/FTC/TAF among TN, VS TE and VU TE PLWH
Time frame: week 48
• Describe treatment emergent resistance profile among participants with confirmed virologic failure with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.
Time frame: week 48
• Describe the change of CD4
Time frame: week 48
• Factors associated with virologic suppression (HIV RNA<50 copies/mL, FDA Snapshot), confirmed virologic failure (HIV RNA ≥200 copies/mL), discontinuation, and emergence of resistance-associated mutations at failure among TN, VS TE and VU TE.
Time frame: week 48
• Describe the change of CD8 cell counts
Time frame: Week 48
• Describe the change CD4/CD8 ratio
Time frame: Week 48
• Describe the change of BMI
Time frame: Week 48
• Describe the change of body weight
Time frame: Week 48
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 14 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Aïda BENALYCHERIF contact
Roland LANDMAN principal investigator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 and Public Universal Healthcare Insurance Coverage, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
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 4 inclusion and 2 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 14 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 Roland LANDMAN (40 25 63 54 ext. +33 1, landman.roland@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
i. HIV RNA ≥50 copies/mL at week 48 within the time window OR One HIV RNA ≥50 copies/mL followed by treatment discontinuation before week 48 after reaching HIV RNA < 50 copies/mL (time frame: Week 48). The study lists 7 primary outcomes in all. 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 14 Aug 2025.