Pre-Exposure Prophylaxis of HIV Infection Clinical Trial
Official title:
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
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.
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