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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04939311
• Other study ID #: VITAL HIV
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 1, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Infection
• Inflammation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Priscilla Hsue, MD	University of California, Los Angeles, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in non-calcified plaque progression	Change in non-calcified plaque progression from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)	1 year (Baseline and Week 52)
Other	Change in high risk plaque	Change in high-risk plaque from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)	1 year (Baseline and Week 52)
Other	Incidence of new lesions	Incidence of new lesions from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)	1 year (Baseline and Week 52)
Primary	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	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	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	1 year (Change from baseline to week 24 and baseline to week 52)
Secondary	Change in Monocyte Activation	Change in Co-expression of CD14/CD16 on Monocytes from baseline to week 24 and baseline to week 52	1 year (Change from baseline to week 24 and baseline to week 52)