Africa Medical and Behavioral Sciences Organization
The GS-US-412-5624 study is a Phase 3, multicentre, randomized, double-blind clinical trial sponsored by Gilead Sciences to evaluate the safety and efficacy of twice-yearly subcutaneous lenacapavir (LEN) and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for HIV pre-exposure prophylaxis (PrEP) in adolescent girls and young women at risk of HIV infection.
The study compares these interventions with the current standard oral PrEP regimen while assessing safety, HIV prevention efficacy, adherence, and participant preferences.
1. To evaluate the efficacy of lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV-1 infection compared with the estimated background HIV-1 incidence rate in adolescent girls and young women (AGYW) at risk of HIV infection.
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women
Linda-Gail Bekker 1, Moupali Das 1, Quarraisha Abdool Karim 1, Khatija Ahmed 1, Joanne Batting 1, William Brumskine 1, Katherine Gill 1, Ishana Harkoo 1, Manjeetha Jaggernath 1, Godfrey Kigozi 1, Noah Kiwanuka 1, Philip Kotze 1, Limakatso Lebina 1, Cheryl E Louw 1, Moelo Malahleha 1, Mmatsie Manentsa 1, Leila E Mansoor 1, Dhayendre Moodley 1, Vimla Naicker 1, Logashvari Naidoo 1, Megeshinee Naidoo 1, Gonasagrie Nair 1, Nkosiphile Ndlovu 1, Thesla Palanee-Phillips 1, Ravindre Panchia 1, Saresha Pillay 1, Disebo Potloane 1, Pearl Selepe 1, Nishanta Singh 1, Yashna Singh 1, Elizabeth Spooner 1, Amy M Ward 1, Zwelethu Zwane 1, Ramin Ebrahimi 1, Yang Zhao 1, Alexander Kintu 1, Chris Deaton 1, Christoph C Carter 1, Jared M Baeten 1, Flavia Matovu Kiweewa 1; PURPOSE 1 Study Team
The New England Journal of Medicine, 2024 · DOI: 10.1056/NEJMoa2407001
Protocol Title
GS-US-412-5624: A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection
Study Site
Masaka Site
Dr. Nakigozi Getrude
Board Member
Dr. Nalugoda Fred
Board Member
Gilead Sciences, Inc
Contact our research team to learn about eligibility and how to get involved.
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