Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Sponsored by Gilead Sciences
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria:
- Incidence Phase
- HIV-1 status unknown at initial screening and no prior human immunodeficiency
virus ( HIV)-1 testing within the last 3 months
- Sexually active (has had > 1 vaginal intercourse within the last 3 months) with
cisgender male individuals (CGM)
- Randomized Phase
- Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with
central HIV-1 testing
- Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening
- Body weight ≥ 35 kg
Key Exclusion Criteria:
- Prior receipt of an HIV vaccine
- Prior use of long-acting systemic pre-exposure prophylaxis (PrEP)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.