Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Recruiting · NCT06902142 · Observational (researchers observe without assigning treatment) · Lead sponsor: Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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.
Where it is running
8 locations listed.
- CHU de Caen - Caen, France
- CHD Vendée - La Roche-sur-Yon, France
- Hôpitaux Civils de Lyon - Lyon, France
- CHU de Nantes - Nantes, France
- CH de Niort - Niort, France
- CHU d'Orléans - Orléans, France
- CHU Pitié-Salpétrière - Paris, France
- CHU de Poitiers - Poitiers, France