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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
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)
Time frame: 1 year (Baseline and Week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
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
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Monocyte Activation
Change in Co-expression of CD14/CD16 on Monocytes from baseline to week 24 and baseline to week 52
Time frame: 1 year (Change from baseline to week 24 and baseline to week 52)