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
    Professor, Medicine. Authored (or co-authored) 162 research publications.

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