Dataset from A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy
(ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg
once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once
daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside
reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or
tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and
background NRTI selection. The primary analysis will take place after the last subject
completes 48 weeks on therapy; an additional analysis will be conducted after the last
subject completes Week 96 on study.