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5 Purpose Studies for Lanacapavir PrEP: Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program
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-PURPOSE 5 trial will evaluate lenacapavir as twice-yearly prevention option in people who could benefit from HIV pre-exposure prophylaxis (PrEP) in France and the United Kingdom -
PURPOSE 5 is the latest example of Gilead's ongoing commitment and work to assess the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. PURPOSE 1 (NCT04994509) is evaluating lenacapavir for PrEP and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP in cisgender adolescent girls and young women ages 16-25 in South Africa and Uganda; this pivotal registrational trial completed full enrolment in September 2023 with more than 5,300 participants enrolled.
PURPOSE 2 (NCT04925752) is assessing lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. PURPOSE 3 will study lenacapavir for PrEP among cisgender women in the United States who are disproportionately affected by HIV, with a focus on Black women and other women of color, and PURPOSE 4 will study lenacapavir for PrEP among people who inject drugs in the United States. PURPOSE 1-5 is the most comprehensive and diverse program for an investigational HIV PrEP program ever conducted. More information about the PURPOSE program can be found at https://www.purposestudies.com/.
"Since Gilead launched the PURPOSE clinical trials in 2019, we have actively engaged a diverse group of global stakeholders who informed not only what we were studying in our innovative HIV prevention research program, but how we conduct that work and continually evolve it," said Jared Baeten MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "There is a critical need to bring forward new PrEP options that are informed by and designed for the communities that could benefit from PrEP in Europe. We are excited to engage with communities and broader stakeholders to inform PURPOSE 5 and partner with them in our goal to develop person-centered innovations that can help end the HIV epidemic in Europe."
Gilead is conducting its PURPOSE program with a commitment to partnering with communities that are disproportionately affected by HIV in their respective countries and regions. Community input on the PURPOSE clinical trials has so far provided critical guidance on issues ranging from program design and community engagement to participant recruitment strategies and important cultural considerations. These kinds of collaborations will continue to help Gilead implement trials with rigor, innovation and intentional inclusion of communities that have traditionally been underrepresented in HIV prevention research.
https://www.gilead.com/news-and-press/press-room/press-releases/2023/10/gilead-sciences-announces-new-clinical-trial-in-europe-to-assess-lenacapavir-for-hiv-prevention-as-part-of-landmark-purpose-program
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