Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
Research type
Research Study
Full title
A Phase 2, Open label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long acting Subcutaneous Lenacapavir for HIV Pre Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP
IRAS ID
1009756
Contact name
Jenna Yaeger
Contact email
Sponsor organisation
Gilead Sciences Inc
Research summary
Human immunodeficiency virus (HIV) attacks the immune system and makes it more likely people will get sick. If HIV is not treated, it can lead to AIDS. Once people get HIV, they have it for life, but with proper treatment HIV can be controlled and people with HIV can live long and \nhealthy lives. Over 1 million new people worldwide get HIV every year, despite global efforts to prevent it. One strategy to prevent the spread of HIV is called Pre-Exposure Prophylaxis (PrEP). “Prophylaxis” means to prevent or control an infection or disease. PrEP is a medicine that people who have a higher chance of getting HIV can take to prevent HIV. \nThere are medicines like F/TDF, also known as Truvada, that are used as PrEP. F/TDF is tablets taken daily. However, some people find it difficult to continue with this kind of PrEP due to the need to take the medicine daily, side effects, and challenges with access to healthcare. \nLenacapavir (LEN), is an approved medicine treating HIV in adults with limited treatment options in multiple regions, including the EU and UK. It is an injection that is given once every 6 months. \nIn this study the researchers will compare LEN and F/TDF in people who would benefit from PrEP. The main goal is to compare six monthly injections of LEN with F/TDF for PrEP, also to learn more about how safe and acceptable LEN is for participants compared with F/TDF. The researchers will also see how LEN is absorbed, modified, and removed from the body.\nThis study, sponsored by Gilead will be run at 14 sexual health clinics in the UK (8 clinics) and France (6 clinics). 262 participants, cisgender men who have sex with men, transgender women, transgender men, cisgender women, and gender nonbinary people, will have about 18 clinic visits and will receive LEN and F/TDF throughout the study if they complete all study phases.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0158
Date of REC Opinion
21 Jun 2024
REC opinion
Further Information Favourable Opinion