RecruitingNot Applicable

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

France120 participantsStarted 2025-02-11

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with virological failure at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06902142

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-01

Contact for this trial

Laurent HOCQUELOUX, M.D.

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

View on ClinicalTrials.gov More HIV Antiretroviral Therapy (ART) Adherence trials