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

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

Sponsors

Lead Sponsor: Priscilla Hsue, MD

Collaborator: University of California, Los Angeles
University of Utah

Source University of California, San Francisco
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.

Overall Status Not yet recruiting
Start Date 2022-07-01
Completion Date 2027-07-01
Primary Completion Date 2026-07-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Target-to-background ratio (TBR) 1 year (Baseline and Week 52)
Secondary Outcome
Measure Time Frame
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)
Change in D-Dimer (ng/mL) 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Markers of Immune Activation 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Monocyte Activation 1 year (Change from baseline to week 24 and baseline to week 52)
Enrollment 110
Condition
Intervention

Intervention Type: Drug

Intervention Name: VB-201

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

Arm Group Label: VB-201

Intervention Type: Drug

Intervention Name: Placebo

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

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

40 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Priscilla Hsue, MD Principal Investigator University of California, San Francisco
Overall Contact

Last Name: Priscilla Hsue, MD

Phone: 628-206-8257

Email: [email protected]

Location
Facility: Contact: Contact Backup: Zuckerberg San Francisco General Hospital Priscilla Hsue, MD 628-206-8257 [email protected]
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of California, San Francisco

Investigator Full Name: Priscilla Hsue, MD

Investigator Title: Chief of Cardiology

Condition Browse
Number Of Arms 2
Arm Group

Label: VB-201

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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