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

Mass General Brigham

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01766726

2012P001138

Details and patient eligibility

About

The main aims of this study are to determine whether: a) ART-naïve HIV+ subjects have increased artherosclerotic plaque inflammation/vulnerability, b) newly-initiated QUAD/Stribild therapy will decrease plaque inflammation/vulnerability in these subjects, and c) QUAD/Stribild therapy will improve indices of immune dysregulation and lipid dysfunction as a mechanism of improved plaque inflammation/vulnerability. Parameters of lipid and immune function will also be assessed in healthy control subjects, for comparison.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

33 participants in 2 patient groups

Healthy control subjects

Description:

Historical healthy control subjects matched to HIV+ patients on traditional cardiovascular risk factors will be studied at baseline with respect to arterial inflammation and coronary atherosclerotic plaque. Prospectively recruited healthy control subjects matched to HIV+ patients on traditional cardiovascular risk factors will be studied at baseline with respect to lipid and immune function.

ART-naïve HIV+ patients starting QUAD/Stribild

Description:

ART-naïve HIV+ patients who are about to be started QUAD/Stribild by their treating clinicians will be studied at baseline and 6 months after initiating QUAD/Stribild therapy.