Study is to find out more about evolocumab in HIV-positive patient`s and with high cholesterol (hyperlipidemia and/or mixed dyslipidemia)

INTERVENTION: Trade Name: Repatha 140 mg solution for injection in pre‐filled pen Product Name: Evolocumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in pre‐filled pen INN or Proposed INN: EVOLOCUMAB Current Sponsor code: AMG 145 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 140‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Evolucumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: EVOLOCUMAB Current Sponsor code: AMG 145 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: HIV and hyperlipidemia or mixed dyslipidemia. ; MedDRA version: 20.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861 ; MedDRA version: 20.1 Level: LLT Classification code 10020667 Term: Hyperlipidemia System Organ Class: 100000004861 ; MedDRA version: 20.0 Level: LLT Classification code 10020180 Term: HIV positive System Organ Class: 100000004848 ; MedDRA version: 20.0 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861 Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: To evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab administered every month (QM) compared with placebo QM on percent change from baseline in low‐density lipoprotein cholesterol (LDL‐C) in human immunodeficiency virus (HIV)‐positive subjects with hyperlipidemia or mixed dyslipidemia. Primary end point(s): Primary endpoint:; *Percent change from baseline in LDL‐C at week 24; Safety endpoints; *Subject incidence of treatment emergent adverse events; *Safety laboratory values and vital signs at each scheduled assessment; *Incidence of anti‐evolocumab antibody (binding and neutralizing) formation Secondary Objective: • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on change from baseline in LDL‐C, and percent change from baseline in non‐high‐density lipoprotein cholesterol (non‐HDL‐C), apolipoprotein B (ApoB), total cholesterol (TC), lipoprotein(a) [Lp(a)], triglycerides, HDL‐C, and very low‐density lipoprotein cholesterol (VLDL‐C), in HIV‐positive subjects with hyperlipidemia or mixed dyslipidemia; • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on percent of subjects attaining LDL‐C < 70 mg/dL (1.8 mmol/L) in HIV‐positive subjects with hyperlipidemia or mixed dyslipidemia; • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on percent of subjects attaining a 50% reduction in LDL‐C from baseline in HIV‐positive subjects with hyperlipidemia or mixed dyslipidemia Timepoint(s) of evaluation of this end point: Day 1, week 12, week 20, week 24, week 36, week 52 SECONDARY OUTCOME: Secondary end point(s): For week 24 the following secondary endpoints will be characterized: ; • Tier 1 ; ‐ Change from baseline in LDL‐C ; ‐ Percent change from baseline in non‐HDL‐C ; ‐ Percent change from baseline in ApoB ; ‐ Percent change from baseline in TC ; ‐ Achievement of target LDL‐C < 70 mg/dL (1.8 mmol/L) ; ‐ LDL‐C response (50% reduction of LDL‐C from baseline) ; • Tier 2 ; ‐ Percent change from baseline in Lp(a) ; ‐ Percent change from baseline in triglycerides ; ‐ Percent change from baseline in HDL‐C ; ‐ Percent change from baseline in VLDL‐C Timepoint(s) of evaluation of this end point: Day 1, week 12, week 20, week 24, week 36, week 52 INCLUSION CRITERIA: * Subject has provided written informed consent * Male or female = 18 years of age at signing of informed consent * Known HIV infection with stable HIV therapy for = 6 months prior to randomization and not expected to change during the duration of study participation. Stable HIV therapy is defined as no new agents added and no dose change of any HIV drug within 6 months prior to randomization * Cluster of differentiation 4 (CD4) = 250 cells/mm3 for = 6 months prior to randomization * HIV viral load = 50 copies/mL at screening and = 200 copies/mL for = 6 months prior to randomization * Subject on stable lipid‐lowering therapy for = 4 weeks prior to randomization and not expected to change during the duration of study participation. Subjects should be on maximally tolerated dose of statins. * Subject without known clinical atherosclerotic CVD (ASCVD): fasting LDL‐C of = 100 mg/dL (2.6 mmol/L) or non‐HDL‐C of = 130 mg/dL (3.4 mmol/L)