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Could a diabetes drug shield the brains of HIV patients?

NCT ID NCT05571319

Disease control Sponsor: University of Stellenbosch 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether metformin, a common diabetes drug, can reduce blood vessel damage in the brain of people living with HIV who also have metabolic syndrome (a cluster of conditions like high blood pressure and cholesterol). The study enrolled 30 adults in South Africa and measured changes in brain blood flow and blood vessel function over 12 weeks. The goal was to see if metformin could help prevent long-term brain problems in this high-risk group.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 2025

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 years and older

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: * Adult (\>18 years); * HIV+ on antiretroviral therapy for at least 12 months prior to study entry; * Viral load ≤50 copies/mL; * Able to provide informed consent; * Metabolic syndrome as per the harmonized criteria; * Women of child-bearing potential willing to use adequate contraception (defined as either an intra-uterine contraceptive device or hormonal contraceptive); Exclusion Criteria: * Treated with metformin as part of care; * History of drug or alcohol abuse within 3 months before screening; * Known neurosyphilis; * Known vitamin B12 deficiency; * Known neuropsychiatric disorders or serious psychiatric symptoms; * Significant head trauma with imaging structural abnormalities; * Renal impairment (estimated glomerular filtration \< 60 mL/min/1.73m2); * Type I or type II diabetes (fasting plasma glucose \>7mmol/L and/or HbA1c \>6.5%); * Hypersensitivity to metformin; * Any contraindication or special precaution in the metformin package insert which may put the participant at a safety risk; * Cationic drugs (as listed in the metformin package insert) that may increase metformin concentrations significantly; * Claustrophobia, metal implants or any other condition that prevents performing MR scan; * Pregnant / breastfeeding;

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome HIV infectious disease HIV Seropositivity metabolic syndrome X

As listed by the trial registrant

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

HIV seropositivity Metabolic syndrome

Contacts and locations

Locations

  • Desmond Tutu Health Foundation: Gugulethu Research Site

    Cape Town, Western Cape, 8001, South Africa

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