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

Recruitingn/aAges 18 Years - anyAllAssociation pour la promotion de la recherche en …
NCT06902142 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tr

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📋 Eligibility rules (as published)
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.
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What it tests

  • Adherence measured by MEMS caps
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Where

8 sites
CHU de Caen
Caen, France
CHD Vendée
La Roche-sur-Yon, France
Hôpitaux Civils de Lyon
Lyon, France
CHU de Nantes
Nantes, France
CH de Niort
Niort, France
CHU d'Orléans
Orléans, France
CHU Pitié-Salpétrière
Paris, France
CHU de Poitiers
Poitiers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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