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

March 31, 2025 updated by: Laurent HOCQUELOUX, MD, Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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):

  • To explore the effectiveness of antiretroviral treatment with B/F/TAF by the rate of virological suppression (plasma HIV-RNA) at 12 months in real life, according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps).
  • Evaluate the risk of emergence of resistance mutations in cases of HIV RNA replication with B/F/TAF.
  • Evaluate the safety profile of B/F/TAF in real-life practice.
  • Evaluate the quality of life of participants treated with B/F/TAF in real-life practice.

Inclusion Criteria -

  • Person living with HIV-1
  • 18 years of age or older
  • Having been informed about the study (non-opposition)
  • Accepts the use of electronic antiretroviral monitoring caps (MEMS caps)
  • Person treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure) Exclusion criteria -
  • Pregnant women
  • People living with HIV (PLHIV) unable to assume responsibility for treatment compliance (impaired judgment, guardianship, institutionalization)
  • PLWH receiving assistance incompatible with the use of the electronic pillbox

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 :

  • Virological failure at 12 months as defined above
  • Rate of side effects measured by CTCAE V.5
  • Emergence of drug resistance mutations according to ANRS AC11 V35 in case of virological replication
  • Quality of life measured by questionnaires

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 :

  • CHU CAEN NORMANDIE
  • CHU d'Orléans
  • APHP Pitié-Salpêtrière
  • CHU Poitiers
  • CHU Nantes
  • CHD La Roche sur Yon
  • CH de Niort
  • HCL Lyon

Project Milestone

  • Expected start date of inclusions: 01/09/2024
  • Inclusion duration: 2 years
  • Duration of follow-up period: 12 months
  • Planned end of study (issue of final report summary 1 year after last visit to last included subject): 01/09/2027

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • CHU de Caen
        • Contact:
      • La Roche sur Yon, France, 85000
      • Lyon, France, 69000
      • Nantes, France, 44000
      • Niort, France, 79000
      • Orléans, France, 45100
        • Recruiting
        • CHU d'Orléans
        • Contact:
        • Contact:
          • Laurent HOCQUELOUX, M.D.
        • Contact:
          • Thierry PRAZUCK, M.D., PhD
      • Paris, France, 75013
      • Poitiers, France, 86000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with virological failure at 6 months
Time Frame: 6 months
Virological failure is defined as a confirmed plasma viral load >50 copies/mL (HIV RNA)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with virological failure at 12 months
Time Frame: 12 months
• Virological failure at 12 months as defined in Primary Outcome Measure
12 months
Proportion of patients with side-effect
Time Frame: 6-12 months
• Side-effect rate measured by CTCAE V.5
6-12 months
Proportion of patients with emerging drug resistance mutations
Time Frame: 6-12 months
• 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
Time Frame: 6-12 months
• Quality of life measured by questionnaires (EQ-5D-5L)
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret

Collaborators

Hôpital Côte de Nacre, CHU de Caen

Investigators

  • Principal Investigator: Laurent HOCQUELOUX, M.D., CHU d'Orléans (France)
  • Study Director: Jean-Jacques PARIENTI, M.D., PhD, CHU de Caen (France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APREMIT 45 (04)
  • CO-FR-380-7223 (Other Grant/Funding Number: GILEAD SCIENCES)
  • 2024-A01111-46 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing may be discussed on a case-by-case basis and will be decided by the BICTECAPS scientific committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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