Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Priscilla Hsue, MD
With
University of California, Los Angeles
University of Utah
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented HIV infection
On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
CD4 T-cell count \> 350 cells/mm3
Male or female between the ages ≥ 40 years of age to \<≤75
Documented cardiovascular disease (1. Prior myocardial infarction, 2. History of percutaneous coronary intervention, 3. History of coronary artery bypass graft OR 4. Angiographic evidence of \>50% stenosis in at least one coronary artery\] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
TBR of \>1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
Female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for \>2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug.
Males must use at least one method of contraception throughout the study.
You may not be if
Pregnant/nursing women
Uncontrolled hypertension or diabetes requiring insulin
AST/ALT or alkaline phosphatase \>2x ULN
Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
Nephrotic syndrome or eGFR \<60 mL/min/1.73m2
Cytopenias which include 1) WBC \<3.5 x103/uL 2) Platelet \<120 x103/uL 3) ANC \<1.5 x103/uL, and absolute lymphocytes \<0.8 x 103/uL
Anemia as fined by \<10 g/dL
Evidence of tuberculosis infection at screening within 30 days prior to screening.
Family history of long QT syndrome, using medication that prolongs QT internal, OR evidence of prolonged QT of \>470 msec as evidenced by ECG
Acute systemic infection within 30 days
On additional immunosuppressant or immunomodulatory therapies
Clareo Health | Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial
