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| ID | Type | Description | Link |
|---|---|---|---|
| CO-FR-380-7223 | Other Grant/Funding Number | GILEAD SCIENCES | |
| 2024-A01111-46 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| Hôpital Côte de Nacre, CHU de Caen | UNKNOWN |
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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
Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR
Type or research Non interventional research (NIR)
Target population People living with HIV (PLWH)
Objectives Primary objective:
- To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay.
Secondary objective(s):
Inclusion Criteria -
Endpoints
Primary :
- Virological failure at 6 months defined as a confirmed plasma viral load >50 copies/mL or a single plasma viral load >200 copies/mL (HIV RNA).
Secondary :
Procedure(s) or visit(s) added by research none
Nomber of patients 120 patients : Accuracy of at least +/-7% on virological failure rate
Number of centers 8 centers :
Project Milestone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy | Given our interest in covering a wide range of adherence profiles of B/F/TAF, the participation of PLHIV perceived by their physicians to be at risk of suboptimal adherence, such as a history of pre-existing resistance that does not affect B/F/TAF, immigrants/migrants, homeless/poorly housed, those with substance use disorders, transgender women, youth and those facing mental health issues, will be encouraged |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence measured by MEMS caps | Device | The methodological choices made in this study are justified by the need to assess the effectiveness of bictegravir, taking into account the varying levels of adherence among PLHIV. The use of electronic antiretroviral caps (MEMS caps: https://aardexgroup.com/medication-event-monitoring-system/ ) and the intra-cellular TAF assay to measure drug concentrations will enable a combined, precise and objective assessment of treatment adherence, and constitute the originality of this research. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virological failure at 6 months | Virological failure is defined as a confirmed plasma viral load >50 copies/mL (HIV RNA) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virological failure at 12 months | • Virological failure at 12 months as defined in Primary Outcome Measure | 12 months |
| Proportion of patients with side-effect | • Side-effect rate measured by CTCAE V.5 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent HOCQUELOUX, M.D. | Contact | +33 2 38 22 95 88 | laurent.hocqueloux@chu-orleans.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent HOCQUELOUX, M.D. | CHU d'Orléans (France) | Principal Investigator |
| Jean-Jacques PARIENTI, M.D., PhD | CHU de Caen (France) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Recruiting | Caen | 14000 | France |
Data sharing may be discussed on a case-by-case basis and will be decided by the BICTECAPS scientific committee
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| 6-12 months |
| Proportion of patients with emerging drug resistance mutations | • Emergence of drug resistance mutations according to ANRS AC11 in case of virological failure | 6-12 months |
| Proportion of patients with good quality of life | • Quality of life measured by questionnaires (EQ-5D-5L) | 6-12 months |
| CHD Vendée | Not yet recruiting | La Roche-sur-Yon | 85000 | France |
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| Hôpitaux Civils de Lyon | Not yet recruiting | Lyon | 69000 | France |
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| CHU de Nantes | Not yet recruiting | Nantes | 44000 | France |
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| CH de Niort | Not yet recruiting | Niort | 79000 | France |
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| CHU d'Orléans | Recruiting | Orléans | 45100 | France |
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| CHU Pitié-Salpétrière | Not yet recruiting | Paris | 75013 | France |
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| CHU de Poitiers | Not yet recruiting | Poitiers | 86000 | France |
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