Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients

Patients with HIV are at higher risk of morbidity and mortality from cardiovascular disease than healthy subjects. Antiretroviral therapy (ART) has greatly increased the lifespan of HIV+ patients, but their risk of CVD remains higher than normal. Previously, it has been shown that compared to healthy control subjects, ART-treated HIV+ patients have more atherosclerotic plaque inflammation in the aorta. This study is intended to determine whether atherosclerotic plaque inflammation/vulnerability is increased in ART-naïve HIV+ patients and whether these parameters can be improved through 6 months of newly-initiated QUAD/Stribild therapy. Additionally, the study will determine whether indices of immune dysregulation and lipid dysfunction are increased in ART-naive HIV+ patients and whether these parameters can also be improved through 6 months of newly initiated QUAD/Stribild therapy.

HIV-infected Subjects:

Inclusion criteria

• men and women, ages 18+, with documented HIV-infection who are ART-naive and ready to be started on ART with QUAD/Stribild by their treating infectious disease doctors

Exclusion criteria

• history of prior, sustained ART use
• CD4 <50 or AIDS-defining illness
• known current opportunistic infection or acute infections (not including Hepatitis B/C)
• pregnancy or breastfeeding
• history of acute coronary syndrome or coronary artery stenting or surgery, diabetes mellitus, or significant autoimmune/inflammatory disease
• plans for sustained use during 6 month study interval of a confounding immune suppressant medication including intravenous or oral corticosteroid
• hemoglobin < 12.5 g/dl for men or < 12 g/dl for women
• eGFR < 70 ml/min/1.73 m2 calculated by CDK-EPI
• contrast dye allergy
• contraindication to beta blockers or nitroglycerin administered during MDCT coronary angiography (coronary CTA) protocol
• body weight > 320 lbs (PET scanner limitation)
• significant radiation exposure (>2 myocardial perfusion scans or CT angiograms) received within the past year
• reported active illicit drug use

Healthy control subjects:

Inclusion criteria

-men and women, ages 18+, without HIV infection

Exclusion criteria

• known current opportunistic infection or acute infections (not including Hepatitis B/C)
• pregnancy or breastfeeding
• history of acute coronary syndrome or coronary artery stenting or surgery, diabetes mellitus, or significant autoimmune/inflammatory disease
• sustained use of a confounding immune suppressant medication including intravenous or oral corticosteroid
• hemoglobin < 12.5 g/dl for men or < 12 g/dl for women
• reported active illicit drug use