A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects. - ND

INTERVENTION:

Product Code: GSK1349752 Pharmaceutical Form: Tablet CAS Number: 1051375‐19‐9 Current Sponsor code: GSK1349752 Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: GSK1349752 Pharmaceutical Form: Tablet CAS Number: 1051375‐19‐9 Current Sponsor code: GSK1349752 Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Tablet INN or Proposed

INN:

Efavirenz Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 600‐ Pharmaceutical Form: Tablet INN or Proposed

INN:

Combinations Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 445‐ Pharmaceutical Form: Tablet INN or Proposed

INN:

Combinations Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 445‐ Pharmaceutical Form: Tablet INN or Proposed

INN:

Combinations Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 900‐ Pharmaceutical Form: Tablet INN or Proposed

INN:

Combinations Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentration number: 900‐

CONDITION:

HIV‐1 infected antiretroviral therapy naïve adult subjects ; MedDRA version: 12.0 Level: LLT Classification code 10064456 Term: HIV infection WHO clinical stage

IV PRIMARY OUTCOME:

Main Objective: To select a GSK1349572 once daily dose for further evaluation in Phase III based on a comparison of the Week 16 antiviral activity and tolerability of a range of oral doses of GSK1349572 in HIV‐1 infected therapy‐naïve adult subjects Primary end point(s): Proportion of subjects with HIV‐1 RNA <50 c/ml through Week 16 using the TLOVR algorithm. Dose selection will be based primarily on antiviral activity and tolerability in conjunction with immunologic, safety and PK measures will also be considered Secondary Objective: To evaluate the effect of various GSK1349572 doses on selected virological and immunological markers of HIV infection through Week 16 To evaluate the safety and tolerability of GSK1349572 doses through Week 16 To characterize the PK parameters of GSK1349572 using intensive and sparse PK sampling strategies and to explore exposure‐response relationships To confirm the Week 16 GSK1349572 once daily selected dose at Week 24 based on antiviral activity in conjunction with immunologic, safety and PK measures To assess the development of viral resistance to GSK1349572 and other on‐study ARTs in subjects experiencing virological failure To evaluate the effect of various demographic factors on exposure‐response parameters of GSK1349572 To assess the HIV‐1 RNA decay rate over the initial 2 weeks of treatment To evaluate the antiviral activity, safety, tolerability and development of viral resistance of the selected dose of GSK1349572 relative to EFV over time

INCLUSION CRITERIA:

1.HIV‐1 infected males or females of non‐childbearing potential ≥18 years of age.For the purposes of this trial, a woman is considered of non‐childbearing potential if she is physiologically incapable of becoming pregnant.This includes pre‐menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy or post‐menopausal women (defined as 12 months of spontaneous amenorrhea) 2.HIV‐1 infection with a screening plasma HIV‐1 RNA ≥1000 c/mL 3. CD4+ cell count ≥100 cells/mm3 (or higher as local guidelines dictate) 4. ART‐naive defined as having <10 days of prior therapy with any antiretroviral agent.Any previous exposure to an HIV integrase inhibitor other than GSK1349572 will be exclusionary. 5.Subject has no evidence of genotypic or phenotypic viral resistance to any antiretroviral drug indicative of primary transmitted resistance in screening genotype or phenotype or historical resistance test result 6.Able