Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir

NCT06902142 | Recruiting

• 3 other identifiers: APREMIT 45 (04)CO-FR-380-72232024-A01111-46
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

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

HIV Antiretroviral Therapy (ART) Adherence

Keywords

HIV-1; B/F/TAF; Adherence; Forgiveness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion of patients with virological failure at 12 months

  12 months

• Proportion of patients with side-effect

  6-12 months

• Proportion of patients with emerging drug resistance mutations

  6-12 months

• Proportion of patients with good quality of life

  6-12 months

Study Arms (1)

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

Device: Adherence measured by MEMS caps

Interventions

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.

Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret: lead
• Hôpital Côte de Nacre, CHU de Caen: collaborator

Study Sites (8)

CHU de Caen

Caen, 14000, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85000, France

NOT YET RECRUITING

Hôpitaux Civils de Lyon

Lyon, 69000, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

CH de Niort

Niort, 79000, France

NOT YET RECRUITING

CHU d'Orléans

Orléans, 45100, France

RECRUITING

CHU Pitié-Salpétrière

Paris, 75013, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

Study Officials

• Laurent HOCQUELOUX, M.D.

  CHU d'Orléans (France)

  PRINCIPAL INVESTIGATOR

• Jean-Jacques PARIENTI, M.D., PhD

  CHU de Caen (France)

  STUDY DIRECTOR

Central Study Contacts

Laurent HOCQUELOUX, M.D.

CONTACT

+33 2 38 22 95 88; laurent.hocqueloux@chu-orleans.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 30, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-02

Locations

FR (8)