Studies how well bictegravir HIV treatment works given patients' adherence
Follows adults with HIV-1 taking bictegravir, tracking virus levels against how closely they take pills.
Plain-language title generated from the registry record
Registry title: Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Key facts
- Where
- Caen, La Roche-sur-Yon, Lyon, Nantes, Niort, Orléans, Paris, and Poitiers, FranceSee the 8 sites
Where in France
- CHU de CAENCaen, FranceTaking people
- CHD VendéeLa Roche-sur-Yon, FranceNot yet recruiting
- Hôpitaux Civils de LyonLyon, FranceNot yet recruiting
- CHU de NantesNantes, FranceNot yet recruiting
- CH de NiortNiort, FranceNot yet recruiting
- CHU d'OrléansOrléans, FranceTaking people
- CHU Pitie SalpetriereParis, FranceNot yet recruiting
- CHU de PoitiersPoitiers, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
- Trial code
- NCT06902142
- Record updated
- 3 April 2025
- Original description
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.Read full original descriptionShow less
Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
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
Inclusion: 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: PLHIV receiving assistance incompatible with the use of the electronic pillbox; 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); Pregnant women.