Condition: HIV Antiretroviral Therapy (ART) Adherence · Sponsor: Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
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
This description comes directly from the study's public registry record.
Laurent HOCQUELOUX, M.D. · +33 2 38 22 95 88 · laurent.hocqueloux@chu-orleans.fr
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| CHU de Caen | Caen, France | Recruiting |
| CHD Vendée | La Roche-sur-Yon, France | Not Yet Recruiting |
| Hôpitaux Civils de Lyon | Lyon, France | Not Yet Recruiting |
| CHU de Nantes | Nantes, France | Not Yet Recruiting |
| CH de Niort | Niort, France | Not Yet Recruiting |
| CHU d'Orléans | Orléans, France | Recruiting |
| CHU Pitié-Salpétrière | Paris, France | Not Yet Recruiting |
| CHU de Poitiers | Poitiers, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06902142