A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

The aim of this study is to determine if virologically suppressed Human Immunodeficiency
Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2
nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed
upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main
objective of the study is to demonstrate the non-inferior antiviral activity of switching to
DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically
suppressed adults living with HIV-1. The study will also evaluate information regarding the
safety and health related quality of life. The study will include Screening Phase (up to 28
days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The
Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately
490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to
52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who
successfully complete up to 52 weeks of treatment will have the opportunity to continue
receiving DTG/3TC FDC once daily in Continuation Phase.