A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled,
multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects
will be randomized 1:1 one of the following treatment arms:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately
394 subjects)

OR

Atripla once daily (approximately 394 subjects)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive
GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access
to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is
locally available-as long as they continue to derive clinical benefit, until they meet a
protocol-defined reason for discontinuation, or until development of the compound is
terminated.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship

Inclusion Criteria:

- Screening plasma HIV-1 RNA ≥1000 c/mL

- Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent
following a diagnosis of HIV-1 infection)

- Ability to understand and sign a written informed consent form

- Willingness to use approved methods of contraception to avoid pregnancy (women of
child bearing potential only)

- Age equal to or greater than 18 years

- A negative HLAB*5701 allele assessment

Exclusion Criteria:

- Women who are pregnant or breastfeeding;

- Active Center for Disease and Prevention Control (CDC) Category C disease

- Hepatic impairment

- HBV co-infection

- Anticipated need for HCV therapy during the study

- Allergy or intolerance to the study drugs or their components or drugs of their class

- Malignancy within the past 5 years

- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening

- Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any
immunomodulator within 28 days of Screening

- Exposure to an agent with documented activity against HIV-1 in vitro or an
experimental vaccine or drug within 28 days of first dose of study medication

- Primary viral resistance in the Screening result

- Verified Grade 4 laboratory abnormality

- ALT >5 xULN

- ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin);

- Estimated creatinine clearance <50 mL/min

- Recent history (≤3 months) of upper or lower gastrointestinal bleed