Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | January 2016 |
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.
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.
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.
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
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