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Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial

Primary Purpose

Inflammation, HIV Infection, Cardiovascular Disease

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VB-201

Placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Zuckerberg San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VB-201

Placebo

Arm Description

One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Outcomes

Primary Outcome Measures

Change in Target-to-background ratio (TBR)

Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)

Secondary Outcome Measures

Change in high sensitivity C-reactive protein (hs-CRP) in mg/L

Change in hs-CRP from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in Interleukin-6 (IL-6) in pg/mL

Change in IL-6 from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in soluble cluster of differentiation (sCD163) ng/mL

Change in sCD163 from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in Lipoprotein (a) [Lp(a)] in mg/dL

Change in Lp(a) from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) in ng/mL

Change in Lp-PLA2 from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in D-Dimer (ng/mL)

Change in D-Dimer from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in Markers of Immune Activation

Change in Co-expression of HLA-DR/CD38 on T-cells from baseline to week 24 and baseline to week 52 as measured by blood collection

Change in Monocyte Activation

Change in Co-expression of CD14/CD16 on Monocytes from baseline to week 24 and baseline to week 52

Full Information

NCT ID

NCT04939311

First Posted

June 3, 2021

Last Updated

September 12, 2022

Sponsor

Priscilla Hsue, MD

Collaborators

University of California, Los Angeles, University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT04939311

Brief Title

Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial

Official Title

Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Funding for this trial has not been established.

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

July 1, 2026 (Anticipated)

Study Completion Date

July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Priscilla Hsue, MD

Collaborators

University of California, Los Angeles, University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, HIV Infection, Cardiovascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VB-201

Arm Type

Experimental

Arm Description

One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

VB-201

Intervention Description

One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Primary Outcome Measure Information:

Title

Change in Target-to-background ratio (TBR)

Description

Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)

Time Frame

1 year (Baseline and Week 52)

Secondary Outcome Measure Information:

Title

Change in high sensitivity C-reactive protein (hs-CRP) in mg/L

Description

Change in hs-CRP from baseline to week 24 and baseline to week 52 as measured by blood collection

Time Frame