Actively Recruiting

Age: 18Years +
All Genders
NCT06902142

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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