Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
CHU de Caen
RECRUITING
Caen
CHD Vendée
NOT_YET_RECRUITING
La Roche-sur-yon
Hôpitaux Civils de Lyon
NOT_YET_RECRUITING
Lyon
CHU de Nantes
NOT_YET_RECRUITING
Nantes
CH de Niort
NOT_YET_RECRUITING
Niort
CHU d'Orléans
RECRUITING
Orléans
CHU Pitié-Salpétrière
NOT_YET_RECRUITING
Paris
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
Contact Information
Primary
Laurent HOCQUELOUX, M.D.
laurent.hocqueloux@chu-orleans.fr
+33 2 38 22 95 88
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Hôpital Côte de Nacre, CHU de Caen
Leads: Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

This content was sourced from clinicaltrials.gov