Genistein for the Reduction of Adverse Cardiovascular Events (GRACE)

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 60

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Summary

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.

Eligibility Criteria

Inclusion Criteria: * age: 19-80 * males and females * all ethnicities * no history of cardiovascular disease * HIV positive participants (30 volunteers, experimental group) * HIV positive participants (30 volunteers, control group) Exclusion Criteria: * if HIV positive: detectable viral load or CD4\3X ULN, total bilirubin greater than 1.5 times ULN) * hormone replacement therapy (HRT) * thyroid supplements * renal dysfunction (eGFR less than 25 mL/min/1.73 m2) * uncontrolled diabetes (HgbA1c\>10%) * coagulopathies * cytopenia (leukocytopenia, hemoglobin\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07785388). StuddyBuddy aggregates publicly available trial information.