Actively Recruiting
Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Led by Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret · Updated on 2025-04-03
120
Participants Needed
8
Research Sites
133 weeks
Total Duration
On this page
Sponsors
A
Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
Lead Sponsor
H
Hôpital Côte de Nacre, CHU de Caen
Collaborating Sponsor
AI-Summary
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
CONDITIONS
Official Title
Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People living with HIV-1
- Age 18 years or older
- Informed about the study (non-opposition)
- Agree to use electronic antiretroviral monitoring caps (MEMS caps)
- Treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF), including treatment-naive, switching treatment, or virological failure cases
You will not qualify if you...
- Pregnant women
- People living with HIV who have impaired judgment, are under guardianship, or institutionalized
- People receiving assistance incompatible with using the electronic pillbox
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
CHU de Caen
Caen, France, 14000
Actively Recruiting
2
CHD Vendée
La Roche-sur-Yon, France, 85000
Not Yet Recruiting
3
Hôpitaux Civils de Lyon
Lyon, France, 69000
Not Yet Recruiting
4
CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
5
CH de Niort
Niort, France, 79000
Not Yet Recruiting
6
CHU d'Orléans
Orléans, France, 45100
Actively Recruiting
7
CHU Pitié-Salpétrière
Paris, France, 75013
Not Yet Recruiting
8
CHU de Poitiers
Poitiers, France, 86000
Not Yet Recruiting
Research Team
L
Laurent HOCQUELOUX, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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