Dataset from A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults (ING111521)

GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV
infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging,
placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect,
safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10
days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an
integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral
therapy. This study consists of a screening visit, a treatment period and a follow-up
evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or
placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.