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.
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.
Adult patients (18 years and older) who receive treatment for HIV in the MUSC Infectious Diseases Clinic will be offered participation in this study. This study will asses whether receipt of injectable HIV therapy at home with a Home Health provider is as safe and effective as receiving treatment in clinic. Participants receiving injectable HIV therapy prescribed by their primary HIV physician will choose to receive the injections once a month or once every two months at home or in a clinic setting and will have the option to change where they receive treatment at any time. A post-administration satisfaction survey, either once a month or once every two months. Participation in the study is expected to last approximately one year.