Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
Launched by CENTRE DE RECHERCHES ET D'ETUDE SUR LA PATHOLOGIE TROPICALE ET LE SIDA · Jan 23, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the real-world use of a medication called Lenacapavir (LEN) for people living with HIV-1 who have had trouble with other treatments. LEN, which is a new type of drug that helps fight HIV, was found to be effective in a previous trial, where many patients achieved low levels of the virus in their blood. The goal of this new study is to gather information about how well LEN works in everyday settings in France, particularly looking at different patient profiles and whether patients continue their treatment over time.
To be eligible for this study, participants must be adults aged 18 and older with HIV-1 infection who have started treatment with LEN and an optimized background regimen since June 20, 2023. Participants will have their health information collected to help researchers understand how LEN is being used and the reasons why some patients may stop treatment. This study is important because it will provide valuable insights into the effectiveness of LEN in treating HIV in a real-world context, contributing to better care for patients.
Gender
ALL
Eligibility 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.
About Centre De Recherches Et D'etude Sur La Pathologie Tropicale Et Le Sida
The Centre de Recherches et d'Étude sur la Pathologie Tropicale et le Sida is a leading research institution dedicated to advancing knowledge and treatment of tropical diseases and HIV/AIDS. With a focus on innovative clinical trials, the center collaborates with international partners to develop effective therapeutic strategies and improve health outcomes in affected populations. Its multidisciplinary team employs cutting-edge methodologies and ethical practices to ensure rigorous scientific investigation, contributing significantly to the global understanding and management of these pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, Ile De France, France
Patients applied
Trial Officials
Romain PALICH, MD
Principal Investigator
Pitie-Salpetriere Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported