The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for prevention of HIV in the Cisgender women in the US.
The primary objectives of this study are:
- To characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women.
- To evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women.
- To evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States