Dataset from A Phase III Randomized, Double-blind Study to Demonstrate the Antiviral Activity of Dolutegravir (DTG) 50 mg Twice Daily Versus Placebo Both Co-Administered With a Failing Antiretroviral Regimen Over Seven Days, Followed by an Open Label Phase With All Subjects Receiving DTG 50 mg Twice Daily Co-administered With an Optimised Background Regimen (OBR) in HIV-1 Infected, Integrase Inhibitor Therapy-Experienced and Resistant, Adults

Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-
controlled, functional monotherapy phase to quantify the antiviral activity attributable to
dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological
failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with
evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be
randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current
failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At
Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg
BID with an optimized background regimen containing at least one fully active drug.