Abstract: Cabotegravir LA (CAB LA) is a long-acting injectable integrase inhibitor, also known as GSK 1265744 LA or 744 LA. This is a Phase 2b/3 study designed to establish the efficacy of CAB LA for pre-exposure prophylaxis (PrEP) in HIV-uninfected men who have sex with men (MSM) and in transgender women (TGW). Small single-dose and multiple-dose studies and Phase 2a safety/tolerability studies have been performed for CAB LA. This PrEP efficacy study is the next developmental investigation of CAB LA in healthy, HIV-uninfected MSM and TGW. CAB LA is the first antiretroviral (ARV) drug being studied as an intervention for HIV prevention prior to regulatory approval of the drug for HIV treatment. A parallel development program for use of cabotegravir (oral and injectable) for treatment of HIV-infected individuals is currently in Phase 2b studies with a salutary safety and efficacy profile to date.

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Project Number: 5um1ai068619-11