NCT06902142Recruiting
Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir
Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 14 Mar 2025
- Start date
- 11 Feb 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
- Diseases
- HIV
- NCT number
- NCT06902142
What you commit to
- Study type: Observational
- Planned participants: 120
- From 11 Feb 2025 to the primary completion date, 1 Sept 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PLHIV receiving assistance incompatible with the use of the electronic pillbox.
Other illness
- 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)
Other
- Pregnant women
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Not yet recruiting |
| Hôpitaux Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| CH de Niort Coordinator of this site? Confirm its status | Niort | France | Not yet recruiting |
| CHU d'Orléans Coordinator of this site? Confirm its status | Orléans | France | Recruiting |
| CHU Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.