A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of fixed dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Plus Lopinavir/Ritonavir (Kaletra) in Adult HIV-1 Infected Subjects With Raised Cholesterol - ROCKET II- Randomized Open Label Switch for Cholesterol Elevation on Kivexa+Kaletra Evaluation Trial

INTERVENTION:

Trade Name: TRUVADA Pharmaceutical Form: Film‐coated tablet 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: Kaletra Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

Lopinavir CAS Number: 192725‐17‐0 Current Sponsor code: LPV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed

INN:

Ritonavir CAS Number: 155213‐67‐5 Current Sponsor code: RTV Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐

CONDITION:

Adult HIV‐1 infected subjects on a stable HAART regimen of Kivexa + Kaletra, with raised cholesterol ; MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV‐1

PRIMARY OUTCOME:

Main Objective: To determine if switching the NRTI backbone from a Kivexa to Truvada leads to a reduction in fasting total cholesterol at 12 weeks. Primary end point(s): The primary efficacy endpoint is change from baseline in total cholesterol at Week 12. Secondary Objective: • Evaluation of fasting metabolic parameters (e.g., LDL, HDL, non‐HDL cholesterol, triglycerides, 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:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: • = 18 years old • Plasma HIV 1 RNA < 50 copies/mL at Screening and = 12 weeks prior to Screening • Stable HAART regimen of Kivexa + Kaletra for = 24 weeks prior to Screening • Documented confirmed raised total cholesterol = 5.2 mmol/L (= 200 mg/dL) for the last two consecutive tests (at least 4 weeks apart) with the last result = 4 weeks prior to Screening • Fasted total cholesterol = 5.2 mmol/L (= 200 mg/dL) at 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 C