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Soy compound could tame HIV-Related inflammation and protect the heart

NCT ID NCT07785388

Disease control Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether genistein, a natural compound found in soy, can reduce inflammation and improve blood vessel health in people living with HIV. Even with effective HIV treatment, the body stays inflamed, raising the risk of heart disease and other problems. The study gives 60 HIV-positive adults either genistein or a placebo for 12 weeks, then measures inflammation, blood vessel function, and pain levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
genistein (a natural compound from soy)
What this could lead to
If it works, genistein could become a safe, affordable way to lower inflammation and heart disease risk in people living with HIV.
What could go wrong
This is an early-stage trial with only 60 participants, so results may not apply broadly. Genistein may not reduce inflammation enough to make a difference, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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\<350 * use cannabis containing only cannabidiol (CBD) * ingest oral tetrahydrocannabinol (THC) * unable to provide a receipt for the cannabis product(s)they ingest * consume soy products, genistein, isoflavonoids, and/or resveratrol * pregnant * breastfeeding * endometriosis * uterine fibroids * have cancer (breast cancer, predisposition to cancer such as abnormal mammogram, family history, BRCA1/BRCA2 positive) * liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>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\<9 mg/dl, platelets\<100x103/mm3) * upper extremity digits/limbs that prevent adequate vascular function test signal acquisition * under the effect of vasodilators * medical conditions which prohibit blood flow occlusion in both arms * allergic to genistein or inulin

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Conditions

The condition(s) this trial relates to.

agnosia cardiovascular disorder HIV infectious disease Inflammation inflammatory disease vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Inflammation Pain management Vascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • London Regional Health Science Centre

    London, Ontario, N6A 5A5, Canada

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