Evaluating the effectiveness of a new HIV treatment based on patient adherence
Étude Multicentrique Prospective de la Relation Entre Efficacité Virologique et Observance Chez Des Patients Infectés Par le VIH-1 Traités Par Bictegravir
Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret · NCT06902142
This study is testing a new HIV treatment to see how well it works for people who stick to their medication schedule and how it affects their overall health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret (other) |
| Locations | 8 sites (Caen and 7 other locations) |
| Trial ID | NCT06902142 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older living with HIV-1 who are starting or changing treatment to B/F/TAF.
Not a fit: Patients who are pregnant, institutionalized, or unable to use electronic monitoring caps may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for HIV patients with varying levels of adherence.
How similar studies have performed: Other studies have shown promising results with similar adherence-focused approaches in HIV treatment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Caen and 7 other locations
- CHU de Caen — Caen, 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)
- CHU d'Orléans — Orléans, France (RECRUITING)
- CHU Pitié-Salpétrière — Paris, France (NOT_YET_RECRUITING)
- CHU de Poitiers — Poitiers, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Antiretroviral Therapy Adherence, HIV-1, B/F/TAF, Adherence, Forgiveness