An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744) in HIV Uninfected Chinese Men

The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for
prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor
currently in development for treatment and prevention of HIV infection. CAB possesses
attributes that allow formulation and delivery as a LA parenteral product. CAB is being
developed as both oral and long acting (LA) injectable formulations. This study is designed
to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected
Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral
CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during
injection phase of the study. Approximately 60 subjects will be screened, of which,
approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection
phase of the study. The maximum study duration will be approximately 89 weeks including oral
phase, injection phase and follow-up phase.