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

NCT04939311 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: VITAL HIV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; HIV Infection; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year (Baseline and Week 52)

Secondary Outcomes (8)

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

  1 year (Change from baseline to week 24 and baseline to week 52)

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

  1 year (Change from baseline to week 24 and baseline to week 52)

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

  1 year (Change from baseline to week 24 and baseline to week 52)

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

  1 year (Change from baseline to week 24 and baseline to week 52)

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

  1 year (Change from baseline to week 24 and baseline to week 52)

Other Outcomes (3)

• Change in non-calcified plaque progression

  1 year (Baseline and Week 52)

• Change in high risk plaque

  1 year (Baseline and Week 52)

• Incidence of new lesions

  1 year (Baseline and Week 52)

Study Arms (2)

VB-201

EXPERIMENTAL

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

Drug: VB-201

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VB-201 DRUG

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

VB-201

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Priscilla Hsue, MD: lead
• University of California, Los Angeles: collaborator
• University of Utah: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Inflammation; HIV Infections; Cardiovascular Diseases

Interventions

1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Priscilla Hsue, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiology

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)