Dataset from A Single-arm Study of the Safety, Efficacy and Central Nervous System and Plasma PK of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily in Combination With the Abacavir/Lamivudine Fixed Dose Combination Tablet Over 96 Weeks in HIV-1 Infected Antiretroviral Naive Adult Subjects

ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be
conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.
Subjects who fulfill eligibility requirements will receive dolutegravir (DTG) 50 mg once
daily in combination with the fixed dose dual nucleoside reverse transcripatase
inhibitor(NRTI) abacavir/lamivudine (ABC/3TC) for 96 weeks. One pair of pharmacokinetic (PK)
samples in plasma and cerebral spinal fluid (CSF) (matching time) for determination of DTG
concentration will be collected at Week 2 and Week 16. Samples for plasma HIV-1 RNA will be
collected at Baseline and various time points throughout the study and samples for HIV-1 RNA
levels in the CSF will be collected at Baseline, Week 2 and Week 16. Safety, additional
measures of antiviral activity and development of viral resistance will also be evlauated.
The primary analysis will take place after the last subject completes 16 weeks on therapy;
additional analyses will be conducted after the last subject completes Weeks 2 and 96 (end of
study).