A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults

This study will compare safety, efficacy, and tolerability of a two drug regimen of
dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two
nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose
combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected
adult subjects that have not previously received antiretroviral therapy. The study is
designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that
of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability
and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised
1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1
ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4)
cell count.