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 HIV-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 disoproxil fumarate
[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 + 3TC regimen to that of DTG + 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.