Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial
NCT ID: NCT04939311
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-07-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VB-201
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
VB-201
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Placebo
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Placebo
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Interventions
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VB-201
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Placebo
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
40 Years
75 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of Utah
OTHER
Priscilla Hsue, MD
OTHER
Responsible Party
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Priscilla Hsue, MD
Chief of Cardiology
Principal Investigators
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Priscilla Hsue, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Countries
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Other Identifiers
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VITAL HIV
Identifier Type: -
Identifier Source: org_study_id
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