HIV Antiretroviral Therapy (ART) AdherenceBICTECAPSNCT06902142
Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
An observational study of HIV Antiretroviral Therapy (ART) Adherence, run by Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret at 8 sites in France.
Trial summary
Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Antiretroviral Therapy (ART) Adherence
- What is being tested?
- Adherence measured by MEMS caps
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 8 sitesFrance
- Study dates
- 11 Feb 2025to 1 Sep 2027
- How long will I take part?
- 12 Months
- 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: Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy
Who may be able to join
- People living with HIV-1
- Age greater than or equal to 18 years
- Having been informed about the study (non-opposition)
- Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)
- People treated or starting treatment with bictegravir//emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure)
Who cannot join
- Pregnant women
- People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)
- PLHIV receiving assistance incompatible with the use of the electronic pillbox.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU de Caen
Caen, 14000
Jean-Jacques PARIENTI, M.D., PhD, +33 2 31 06 57 74, parienti-jj@chu-caen.fr
- Not yet recruiting
CHD Vendée
La Roche-sur-Yon, 85000
Dominique MERRIEN, M.D., dominique.merrien@ght85.fr
- Not yet recruiting
Hôpitaux Civils de Lyon
Lyon, 69000
Agathe BECKER, M.D., agathe.becker01@chu-lyon.fr
- Not yet recruiting
CHU de Nantes
Nantes, 44000
Clotilde ALLAVENA, M.D., clotilde.allavena@chu-nantes.fr
- Not yet recruiting
CH de Niort
Niort, 79000
Simon SUNDER, M.D., simon.sunder@ch-niort.fr
- Recruiting
CHU d'Orléans
Orléans, 45100
Laurent HOCQUELOUX, +33 2 38 22 95 88, laurent.hocqueloux@chu-orleans.fr
Laurent HOCQUELOUX, M.D.
- Not yet recruiting
CHU Pitié-Salpétrière
Paris, 75013
Romain PALICH, M.D., romain.palich@aphp.fr
- Not yet recruiting
CHU de Poitiers
Poitiers, 86000
Gwénaël LE MOAL, M.D., gwenael.le-moal@chu-poitiers.fr
About this study
Official title: Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.
The investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B/F/TAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.
Read more
The study is planned to include 120 patients with HIV infection treated with B/F/TAF, over a planned 2-year period with usual follow-up.
The aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).
The investigators hope to generate real-life data on B/F/TAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.
. Key words : HIV-1 ; B/F/TAF ; Adherence ; Forgiveness
Read the detailed description
Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR
Type or research Non interventional research (NIR)
Target population People living with HIV (PLWH)
Objectives Primary objective:
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay.
Secondary objective(s):
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by the rate of virological suppression (plasma HIV-RNA) at 12 months in real life, according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps).
- Evaluate the risk of emergence of resistance mutations in cases of HIV RNA replication with B/F/TAF.
- Evaluate the safety profile of B/F/TAF in real-life practice.
- Evaluate the quality of life of participants treated with B/F/TAF in real-life practice.
Inclusion Criteria -
- Person living with HIV-1
- 18 years of age or older
- Having been informed about the study (non-opposition)
- Accepts the use of electronic antiretroviral monitoring caps (MEMS caps)
- Person treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure) Exclusion criteria -
- Pregnant women
- People living with HIV (PLHIV) unable to assume responsibility for treatment compliance (impaired judgment, guardianship, institutionalization)
- PLWH receiving assistance incompatible with the use of the electronic pillbox
Endpoints
Primary :
- Virological failure at 6 months defined as a confirmed plasma viral load >50 copies/mL or a single plasma viral load >200 copies/mL (HIV RNA).
Secondary :
- Virological failure at 12 months as defined above
- Rate of side effects measured by CTCAE V.5
- Emergence of drug resistance mutations according to ANRS AC11 V35 in case of virological replication
- Quality of life measured by questionnaires
Procedure(s) or visit(s) added by research none
Nomber of patients 120 patients : Accuracy of at least +/-7% on virological failure rate
Number of centers 8 centers :
- CHU CAEN NORMANDIE
- CHU d'Orléans
- APHP Pitié-Salpêtrière
- CHU Poitiers
- CHU Nantes
- CHD La Roche sur Yon
- CH de Niort
- HCL Lyon
Project Milestone
- Expected start date of inclusions: 01/09/2024
- Inclusion duration: 2 years
- Duration of follow-up period: 12 months
- Planned end of study (issue of final report summary 1 year after last visit to last included subject): 01/09/2027
- Being tested
- Adherence measured by MEMS caps
- Keywords
- HIV-1, B/F/TAF, Adherence, Forgiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence measured by MEMS capsDevice
The methodological choices made in this study are justified by the need to assess the effectiveness of bictegravir, taking into account the varying levels of adherence among PLHIV. The use of electronic antiretroviral caps (MEMS caps: https://aardexgroup.com/medication-event-monitoring-system/ ) and the intra-cellular TAF assay to measure drug concentrations will enable a combined, precise and objective assessment of treatment adherence, and constitute the originality of this research.
| Study group | Role | What they receive |
|---|---|---|
| Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy | Given our interest in covering a wide range of adherence profiles of B/F/TAF, the participation of PLHIV perceived by their physicians to be at risk of suboptimal adherence, such as a history of pre-existing resistance that does not affect B/F/TAF, immigrants/migrants, homeless/poorly housed, those with substance use disorders, transgender women, youth and those facing mental health issues, will be encouraged Receives: Device: Adherence measured by MEMS caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with virological failure at 6 months
Virological failure is defined as a confirmed plasma viral load >50 copies/mL (HIV RNA)
Measured: 6 months
Secondary outcomes (4)
Proportion of patients with virological failure at 12 months
- Virological failure at 12 months as defined in Primary Outcome Measure
Measured: 12 months
Proportion of patients with side-effect
- Side-effect rate measured by CTCAE V.5
Measured: 6-12 months
Proportion of patients with emerging drug resistance mutations
- Emergence of drug resistance mutations according to ANRS AC11 in case of virological failure
Measured: 6-12 months
Proportion of patients with good quality of life
- Quality of life measured by questionnaires (EQ-5D-5L)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start11 Feb 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Antiretroviral Therapy (ART) AdherenceStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Côte de Nacre, CHU de Caen
- Responsible party
- Principal investigator, Laurent HOCQUELOUX, MD, Centre Hospitalier Régional d'Orléans
- Investigators
- Laurent HOCQUELOUX, M.D., Principal investigator, CHU d'Orléans (France)Jean-Jacques PARIENTI, M.D., PhD, Study director, CHU de Caen (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902142
- Sponsor's protocol ID
- APREMIT 45 (04)
- Other IDs
- CO-FR-380-7223, 2024-A01111-46
- Acronym
- BICTECAPS
- Status last verified
- Feb 2025
- First submitted
- 14 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing may be discussed on a case-by-case basis and will be decided by the BICTECAPS scientific committee
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
- ClinicalTrials.gov ID
- NCT06902142
- Acronym / sponsor ID
- BICTECAPS / APREMIT 45 (04)
- Keywords
- HIV-1, B/F/TAF, Adherence, Forgiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le LoiretUniversity, hospital or other
- Collaborators
- Hôpital Côte de Nacre, CHU de Caen
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Mar 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.
Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.
The investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B/F/TAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.
The study is planned to include 120 patients with HIV infection treated with B/F/TAF, over a planned 2-year period with usual follow-up.
The aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).
The investigators hope to generate real-life data on B/F/TAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.
. Key words : HIV-1 ; B/F/TAF ; Adherence ; Forgiveness
Detailed description
Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR
Type or research Non interventional research (NIR)
Target population People living with HIV (PLWH)
Objectives Primary objective:
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay.
Secondary objective(s):
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by the rate of virological suppression (plasma HIV-RNA) at 12 months in real life, according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps).
- Evaluate the risk of emergence of resistance mutations in cases of HIV RNA replication with B/F/TAF.
- Evaluate the safety profile of B/F/TAF in real-life practice.
- Evaluate the quality of life of participants treated with B/F/TAF in real-life practice.
Inclusion Criteria -
- Person living with HIV-1
- 18 years of age or older
- Having been informed about the study (non-opposition)
- Accepts the use of electronic antiretroviral monitoring caps (MEMS caps)
- Person treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure) Exclusion criteria -
- Pregnant women
- People living with HIV (PLHIV) unable to assume responsibility for treatment compliance (impaired judgment, guardianship, institutionalization)
- PLWH receiving assistance incompatible with the use of the electronic pillbox
Endpoints
Primary :
- Virological failure at 6 months defined as a confirmed plasma viral load >50 copies/mL or a single plasma viral load >200 copies/mL (HIV RNA).
Secondary :
- Virological failure at 12 months as defined above
- Rate of side effects measured by CTCAE V.5
- Emergence of drug resistance mutations according to ANRS AC11 V35 in case of virological replication
- Quality of life measured by questionnaires
Procedure(s) or visit(s) added by research none
Nomber of patients 120 patients : Accuracy of at least +/-7% on virological failure rate
Number of centers 8 centers :
- CHU CAEN NORMANDIE
- CHU d'Orléans
- APHP Pitié-Salpêtrière
- CHU Poitiers
- CHU Nantes
- CHD La Roche sur Yon
- CH de Niort
- HCL Lyon
Project Milestone
- Expected start date of inclusions: 01/09/2024
- Inclusion duration: 2 years
- Duration of follow-up period: 12 months
- Planned end of study (issue of final report summary 1 year after last visit to last included subject): 01/09/2027
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy | – | Device: Adherence measured by MEMS capsGiven our interest in covering a wide range of adherence profiles of B/F/TAF, the participation of PLHIV perceived by their physicians to be at risk of suboptimal adherence, such as a history of pre-existing resistance that does not affect B/F/TAF, immigrants/migrants, homeless/poorly housed, those with substance use disorders, transgender women, youth and those facing mental health issues, will be encouraged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy
Key inclusion criteria (5 listed)
- People living with HIV-1
- Age greater than or equal to 18 years
- Having been informed about the study (non-opposition)
- Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)
- People treated or starting treatment with bictegravir//emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure)
Key exclusion criteria (3 listed)
- Pregnant women
- People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)
- PLHIV receiving assistance incompatible with the use of the electronic pillbox.
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 |
|---|---|---|
| Adherence measured by MEMS capsThe methodological choices made in this study are justified by the need to assess the effectiveness of bictegravir, taking into account the varying levels of adherence among PLHIV. The use of electronic antiretroviral caps (MEMS caps: https://aardexgroup.com/medication-event-monitoring-system/ ) and the intra-cellular TAF assay to measure drug concentrations will enable a combined, precise and objective assessment of treatment adherence, and constitute the originality of this research. | Device | Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy |
Primary outcome
Proportion of patients with virological failure at 6 months
Time frame: 6 months
Virological failure is defined as a confirmed plasma viral load >50 copies/mL (HIV RNA)
4 secondary outcomes
Proportion of patients with virological failure at 12 months
Time frame: 12 months
Proportion of patients with side-effect
Time frame: 6-12 months
Proportion of patients with emerging drug resistance mutations
Time frame: 6-12 months
Proportion of patients with good quality of life
Time frame: 6-12 months
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 3 Apr 2025.
- Individual participant dataSharing planned: Undecided. Data sharing may be discussed on a case-by-case basis and will be decided by the BICTECAPS scientific committee
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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.
Laurent HOCQUELOUX, M.D. principal investigator
CHU d'Orléans (France)
Jean-Jacques PARIENTI, M.D., PhD study director
CHU de Caen (France)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Antiretroviral Therapy (ART) Adherence, run by Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret at 8 sites in France.
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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Laurent HOCQUELOUX, M.D. (+33 2 38 22 95 88, laurent.hocqueloux@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with virological failure at 6 months (time frame: 6 months). 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 3 Apr 2025.