Use of Lenacapavir for HIV-1 treatment in France
Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France: a Retrospective Observational Study (LENAddOn)
This study is testing how well Lenacapavir works as an additional treatment for adults in France who have a tough-to-treat form of HIV-1.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06799338 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the real-world effectiveness of Lenacapavir, a novel capsid inhibitor, as an add-on treatment to an optimized background regimen for adults with multidrug-resistant HIV-1 infection in France. Participants who have received Lenacapavir since its availability on June 20, 2023, will have their data collected to assess viral suppression and overall health outcomes. The study aims to gather insights on the long-term efficacy and safety of Lenacapavir in a clinical setting, contributing to better management strategies for patients with treatment-resistant HIV.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with HIV-1 infection who have received Lenacapavir as part of their treatment regimen.
Not a fit: Patients with HIV-2 infection will not benefit from this study as it focuses exclusively on HIV-1.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with multidrug-resistant HIV-1, improving their viral suppression and overall health.
How similar studies have performed: Previous studies, including the CAPELLA trial, have shown promising results with Lenacapavir, indicating its potential effectiveness in treating multidrug-resistant HIV-1.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years); * With HIV-1 infection; * Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024; * Who did not refuse the collection and use of their data. Exclusion Criteria: \- HIV-2 infection.
Where this trial is running
Paris, Île-de-France Region
- Hôpital Pitié-Salpêtrière — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Romain PALICH, MD — Pitie-Salpetriere Hospital
- Study coordinator: Yasmine DUDOIT
- Email: yasmine.dudoit@aphp.fr
- Phone: +33 (0)1 42 16 41 81
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.