Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociation pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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 design

Treatments tested in this trial

  • Adherence measured by MEMS caps

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

Lead sponsor

Centre Hospitalier Régional d'Orléans

Sponsor institution

Hôpital Côte de Nacre, CHU de Caen

Collaborator