Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02874703
Eligibility Criteria:
HIV positive subjects
Inclusion Criteria:
* age ≥40 and ≤75 years
* documented HIV infection
* participant report that combination antiretroviral therapy (cART) (any regimen) has been taken stably without \> 4 week interruption for at least 180 days prior to study entry (report of switching regimens in that time frame is permissible)
Exclusion Criteria:
* CD4 \< 100 cell/mm3
* current active AIDS-defining illness
* current active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus \[HPV\], or HCV)
* current active cancer
* clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of AMI, ACS, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, PAD), by subject report
* clinical diagnosis of HFpEF or HFrEF, by subject report
* diagnosed DM on antihyperglycemic medication
* current, active use of immune suppressant medication including oral or intravenous corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
* eGFR \<45 ml/min/1.73 m2 calculated by CDK-EPI
* standard contraindications to MRI procedure based on MGH MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium
* use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast rice, niacin or omega-3 fatty acids (\>3 grams/day in standalone formulations) in the 90 days prior to study entry
* use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to study entry
* pregnancy or breastfeeding (female subjects of reproductive potential)
* other medical, psychiatric, or psychological condition that, in the opinion of the study investigator, would interfere with completion of study procedures
HIV negative subjects:
Inclusion Criteria:
• age ≥40 and ≤75 years
Exclusion Criteria:
* HIV infection
* current active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus \[HPV\], or HCV)
* current active cancer
* clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of AMI, ACS, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, PAD), by subject report
* clinical diagnosis of HFpEF or HFrEF, by subject report
* diagnosed DM on antihyperglycemic medication
* current, active use of immune suppressant medication including oral or intravenous corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
* eGFR \<45 ml/min/1.73 m2 calculated by CDK-EPI
* standard contraindications to MRI procedure based on MGH MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium
* use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast rice, niacin or omega-3 fatty acids (\>3 grams/day in standalone formulations) in the 90 days prior to study entry
* use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to study entry
* pregnancy or breastfeeding (female subjects of reproductive potential)
* other medical, psychiatric, or psychological condition that, in the opinion of the study investigator, would interfere with completion of study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02874703
Study Brief:
Protocol Section:
NCT02874703