A Phase 2 Study of BIT225, an Human Immunodeficiency Virus-1 (HIV-1) Vpu Inhibitor, in Treatment Naive HIV 1 Infected Individuals Commencing Dolutegravir-based Combination Antiretroviral Therapy (cART): Evaluation of Safety, Efficacy and Inflammatory and Immune Activation Markers

The proposed study will determine the potential efficacy and safety of a first-in-class HIV-1 Vpu inhibitor, BIT225, The study involves the addition of BIT225 for a 24-week period at commencement of initiation of cART. In a previous 12-week clinical study (BIT225-009, ACTRN12617000025336), in combination with cART in HIV-1 infected treatment naïve subjects, BIT225 was shown to induce immunomodulation effects and improve key markers of health outcomes. This study aims to demonstrate that the addition of BIT225 to cART will result in comparable reductions in plasma viral load, and result in clinically favourable changes in viral, inflammatory and immune activation markers, beyond those seen in the cART alone arm.