People living with HIV (PLHIV) live longer because of modern HIV medicines, but even with these treatments, their bodies are more inflamed. Long term inflammation increases the risk of heart disease, chronic pain, lung disease, dementia, arthritis, and other infections. Because some anti-inflammatory medicines can cause serious side effects, interact with HIV drugs, or be costly, safer and more affordable treatment options are needed. Genistein is a natural compound found in soy foods. It is considered safe and has been shown to reduce inflammation and improve blood vessel health. This study will test whether genistein can lower inflammation in the blood, improve blood vessel health, and reduce pain in PLHIV.
age: 19-80
males and females
all ethnicities
no history of cardiovascular disease
if HIV positive: detectable viral load or CD4<350
use cannabis containing only cannabidiol (CBD)
ingest oral tetrahydrocannabinol (THC)
unable to provide a receipt for the cannabis product(s)they ingest
Parallel
Genistein (Unconjugated Isoflavones 100)
Dietary supplementGenistein: 500 mg twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks
Placebo
DrugPlacebo: twice a day (1000 mg total) for 12 weeks, followed by a washout for 6 weeks
Investigate whether genistein attenuates HIV-induced inflammation.
Blood and urine will be collected at weeks 1 (visit 1, baseline), 4 (visit 2), 8 (visit 3), 12 (visit 4) . The blood samples will be analyzed for inflammatory cytokines and proteins using Olink, SEER and/or NULISA proteomics. Plasma may be sent to Greenstone Biosciences for analysis. Urine will be tested for cannabinoids (THC) and nicotine/cotinine to confirm cannabis and tobacco use, respectively at the UH-LHSCRI Lab.
Investigate whether genistein attenuates HIV-induced vascular dysfunction.
An evaluation of vascular function at weeks 1 (visit 1, baseline), 12 (visit 4) will be assessed by either endothelial peripheral arterial tonometry (EndoPAT) or flow-mediated dilation (FMD) to determine if genistein treatment improves vasodilation and constriction or vascular tone.
Investigate whether genistein reduces pain levels in PLHIV.
Pain Score. Pain will be assessed with an 11-point scale from 0 to 10 as follows: No pain (score of 0) Mild pain (score of 1, 2, or 3): 1 ("very mild"), 2 ("discomforting") or 3 ("tolerable") Moderate pain (score of 4, 5 or 6): 4 ("distressing"), 5 ("very distressing"), 6 ("intense") Severe pain (score of 7, 8, 9 or 10): 7 ("very intense"), 8 ("horrible"), 9 ("Unbearable"), 10 ("Unspeakable")
Investigate whether genistein in PLHIV alters the gut microbiome to reduce levels of inflammation.
Stool will be collected at weeks 1 (visit 1, baseline), 4 (visit 2), 8 (visit 3), 12 (visit 4) and transported to Robarts Research Institute (Laboratory of PI, Dr Mark Chandy) and sent in batches to Greenstone Biosciences (Palo Alto, USA) to assess the effects of genistein on the microbiome.
Exploratory Objective: Induced pluripotent stem cells (iPSC) reprogramming and genetic testing (optional):
We will collect one PAX gene tube (3 mL) for RNA sequencing and send to Greenstone Biosciences (Palo Alto, USA). We will isolate the PBMCs (from the tubes used for serum and plasma collection) and send them to Greenstone Biosciences for iPSC reprogramming (Greenstone Biosciences, Palo Alto, USA).
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Greenstone Biosciences, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
