Use of Lenacapavir for HIV-1 treatment in France

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.