Summary

Eligibility
for people ages 40-75 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Priscilla Hsue, MD
Photo of Priscilla Hsue
Priscilla Hsue

Description

Summary

This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.

Keywords

Inflammation HIV Infection Cardiovascular Disease Cardiovascular Diseases Arteritis

Eligibility

You can join if…

Open to people ages 40-75

  • 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 CAN'T join 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

Location

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Priscilla Hsue, MD
    Professional Experience: Dr. Hsue trained in Internal Medicine in the Molecular Medicine Training Program at UC San Francisco and in Cardiovascular Medicine at UC San Francisco. She served as Chief Cardiology Fellow during this time. She has been on the faculty in the Department of Medicine at San Francisco General Hospital since 2002.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Priscilla Hsue, MD
ID
NCT04939311
Phase
Phase 1/2
Study Type
Interventional
Last Updated