Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia

LDL-C = low density lipoprotein cholesterol QM = once monthly Double blind = neither the
subject, the site staff nor the Sponsor study team will know whether the subject is receiving
either evolocumab or placebo Open label = all subjects receive evolocumab

Inclusion Criteria:

- Male or female ≥ 18 years of age

- Known HIV (human immunodeficiency virus) infection with stable HIV therapy for ≥ 6
months

- Cluster of differentiation 4 (CD4) ≥ 250 cells/mm3 for ≥ 6 months

- HIV viral load ≤ 50 copies/mL at screening and ≤ 200 copies/mL for ≥ 6 months

- Subject on stable lipid-lowering therapy for ≥ 4 weeks prior to randomization and not
expected to change during the duration of study

- For subjects with known clinical astherosclerotic CVD (ASCVD), fasting LDL-C of ≥ 70
mg/dL or non-HDL-C ≥ 100 mg/dL. For subjects without known clinical ASCVD: fasting
LDL-C of ≥ 100 mg/dL or non-HDL-C of ≥ 130 mg/dL

- Fasting triglycerides ≤ 600 mg/dL (6.8 mmol/L)

Exclusion Criteria:

- Taking a combination of background lipid-lowering therapy and HIV therapy known to
have significant drug-drug interaction

- NYHA III or IV heart failure, or last known left ventricular ejection fraction (LVEF)
< 30%

- Known opportunistic infection/AIDS defining illness within 1 year prior to
randomization

- Myocardial infarction, unstable angina, percutaneous coronary intervention,coronary
artery bypass graft or stroke within 3 months

- Type 1 diabetes, new-onset or poorly controlled type 2 diabetes

- Uncontrolled hypertension

- Taken a cholesterylester transfer protein inhibitor in the last 12 months

- Moderate to severe renal dysfunction

- Persistent active liver disease or hepatic dysfunction (Stable chronic hepatitis C of
at least 1 year duration prior to randomization is allowed)

- Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma,breast ductal
carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to
randomization,

- Other Exclusion Criteria May Apply.