This study is for Cisgender Men (CGM), Transgender Women (TGW), Transgender Men (TGM) & Gender Non-binary people (GNB) who have sex with male partners and who are at risk for HIV infection.

The study will test the experimental drug Lenacapavir (LEN) for the prevention of HIV infection, also known as Pre-Exposure Prophylaxis (PrEP). This study will also compare the effectiveness of LEN to Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF; Truvada®), which has already been approved in several countries for use as PrEP.

The primary objective of this study is to determine how bictegravir (BIC) plus lenacapvir (LEN) in two different doses affects an HIV-1 infection in the body compared with current standard treatment regimens. Other objectives are to determine which of these treatments are the most effective for treating HIV-1 infection, the safety and tolerability of these two doses for people with HIV, as well as how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems experienced during the study.