Effects of Newly-Initiated QUAD Therapy on Aortic/Coronary Inflammation in ART-Naïve Infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET
时间窗: Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild
Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
次要结局
- Lipid and lipoprotein levels(Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild)
- Indices of pro-atherogenic lipid dysfunction(Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild)
- Aortic/coronary atherosclerotic plaque on coronary computed tomography angiography (coronary CTA)(Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild)
- Inflammatory biomarker levels(Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild)
- Percentage of circulating activated leukocyte subsets(Baseline and change from baseline to 6 months in HIV cohort starting QUAD/Stribild)
研究者
Steven K. Grinspoon, MD
Professor of Medicine, Harvard Medical School
Massachusetts General Hospital