Evaluating the effectiveness of a new HIV treatment based on patient adherence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of the antiretroviral therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1-infected patients by measuring virological suppression rates at 6 and 12 months. The study will utilize electronic monitoring caps to track adherence patterns and evaluate the relationship between adherence and treatment outcomes. A total of 120 participants will be followed over a two-year period to gather real-life data on the treatment's effectiveness and safety, as well as the quality of life of those treated. The study also aims to investigate the emergence of resistance mutations in cases of HIV RNA replication.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Caen
  Caen, France Recruiting
• CHU d'Orléans
  Orléans, France Recruiting
• CHD Vendée
  La Roche-sur-Yon, France Not yet recruiting
• Hôpitaux Civils de Lyon
  Lyon, France Not yet recruiting
• CHU de Nantes
  Nantes, France Not yet recruiting
• CH de Niort
  Niort, France Not yet recruiting

Study contacts

• Principal investigator: Laurent HOCQUELOUX, M.D. — CHU d'Orléans (France)
• Study coordinator: Laurent HOCQUELOUX, M.D.
• Email: laurent.hocqueloux@chu-orleans.fr
• Phone: +33 2 38 22 95 88

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.