A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching from a Stable HAART Regimen of fixed dose Abacavir/Lamivuidine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol

INTERVENTION:

Trade Name: Atripla Product Name: efavirenz/emtricitabine/tenofovir disoproxil fumarate Product Code: ATR Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

efavirenz CAS Number: 154598‐52‐4 Current Sponsor code: EFV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ INN or Proposed

INN:

emtricitabine CAS Number: 143491‐57‐0 Current Sponsor code: FTC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

tenofovir disoproxil fumarate CAS Number: 52232‐67‐4 Current Sponsor code: TDF Other descriptive name: tenofovir DF Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Kivexa Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

abacavir CAS Number: 136470‐78‐5 Current Sponsor code: ABC Other descriptive name: abacavir sulfate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ INN or Proposed

INN:

lamivudine CAS Number: 134678‐17‐4 Current Sponsor code: 3TC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Sustiva Product Name: efavirenz Product Code: EFV Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

efavirenz CAS Number: 154598‐52‐4 Current Sponsor code: EFV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐

CONDITION:

Adult, HIV‐1 infected, tenofovir DF‐ and emtricitabine‐naive subjects on a stable HAART regimen of Kivexa (abacavir/lamivudine) and efavirenz, with raised total fasting cholesterol ; MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV‐1

PRIMARY OUTCOME:

Main Objective: To determine if switching from a stable HAART regimen of Kivexa + EFV to once daily Atripla leads to a reduction in total fasting cholesterol at 12 weeks. Primary end point(s): Change from baseline in total fasting cholesterol at Week 12. Secondary Objective: •Evaluation of fasting metabolic parameters (e.g., LDL, HDL, triglycerides, non‐HDL cholesterol and cholesterol ratios).; ; • Evaluation of efficacy and safety by assessing adverse events, clinical laboratory tests, physical examinations and vital signs at every visit.; ; • Evaluation of changes in the 10‐year risk factor for coronary heart disease outcomes as measured by total cholesterol, HDL, blood pressure, smoking status, treatment for hypertension, sex and age.

INCLUSION CRITERIA:

• = 18 years old • Plasma HIV RNA < 50 copies/mL = 12 weeks prior to Screening • Stable HAART regimen of Kivexa + EFV for = 24 weeks prior to Screening • Documented confirmed raised total cholesterol = 5.2 mmol/L for last two consecutive tests (at least 4 weeks apart) with the last result = 4 weeks prior to Screening • Subject willing to continue current unmodified HAART for 12 weeks if randomized to Group 2 • Subjects requiring concomitant lipid regulating therapy must be established on a stable dose/frequency = 12 weeks prior to Screening and be expected to remain stable in dose and frequency throughout the treatment phase of the study • Adequate renal function by calculated creatinine clearance = 60 mL/min according to the Cockcroft Gault formula • Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least 2 years post‐menopausal) • Hepatic Total Bilirubin = 22 umol/L • Adequate ha