Clinical trial NCT06902142: Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Official title: Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Keywords: HIV-1
B/F/TAF
Adherence
Forgiveness
Lead sponsor: Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
Sponsor class: OTHER
Collaborators: name: Hôpital Côte de Nacre, CHU de Caen
First posted: 2025-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of patients with virological failure at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients with virological failure at 12 months
timeFrame: 12 months
measure: Proportion of patients with side-effect
timeFrame: 6-12 months
measure: Proportion of patients with emerging drug resistance mutations
timeFrame: 6-12 months
measure: Proportion of patients with good quality of life
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Lyon
country: France
facility: Hôpitaux Civils de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Niort
country: France
facility: CH de Niort
city: Orléans
country: France
facility: CHU d'Orléans
city: Paris
country: France
facility: CHU Pitié-Salpétrière
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: CHU d'Orléans (France)
name: Laurent HOCQUELOUX, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Caen (France)
name: Jean-Jacques PARIENTI, M.D., PhD
role: STUDY_DIRECTOR
References: