NCT06902142 Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
| NCT ID | NCT06902142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret |
| Condition | HIV Antiretroviral Therapy (ART) Adherence |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-02-11 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Laurent HOCQUELOUX, M.D.
PRINCIPAL INVESTIGATOR
CHU d'Orléans (France)
Frequently Asked Questions
Who can join the NCT06902142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Antiretroviral Therapy (ART) Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06902142 currently recruiting?
Yes, NCT06902142 is actively recruiting participants. Contact the research team at laurent.hocqueloux@chu-orleans.fr for enrollment information.
Where is the NCT06902142 trial being conducted?
This trial is being conducted at Caen, France, La Roche-sur-Yon, France, Lyon, France, Nantes, France and 4 additional locations.
Who is sponsoring the NCT06902142 clinical trial?
NCT06902142 is sponsored by Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret. The principal investigator is Laurent HOCQUELOUX, M.D. at CHU d'Orléans (France). The trial plans to enroll 120 participants.
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