NCT05571319CompletedPhase 2
A Pilot Study of Metformin to Reduce Cerebrovascular Dysfunction in Participants With HIV and Metabolic Syndrome.
Study of Metformin to Reduce Cerebrovascular Dysfunction in South African Patients With HIV and Metabolic syndRome: a Pilot Trial.
Source: ClinicalTrials.gov · Last updated 6 Oct 2025
Brief summary (registry, in English)
Metabolic syndrome is a constellation of risk factors for cardiovascular disease and type 2 diabetes mellitus which frequently occur together. Data is emerging suggesting metabolic syndrome causes brain disease by contributing to blood vessel damage and inflammation. People living with HIV (PLWH) are at high risk and the investigators will perform a pilot study of the well-known type 2 diabetes drug metformin to treat this blood vessel damage and inflammation in PLWH.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 28 Jun 2022
- Start date
- 11 Aug 2022
- Primary completion date
- 24 Mar 2025
- Lead sponsor
- University of Stellenbosch
- Diseases
- HIV
- NCT number
- NCT05571319
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 11 Aug 2022 to the primary completion date, 24 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with metformin as part of care;
- History of drug or alcohol abuse within 3 months before screening;
- Cationic drugs (as listed in the metformin package insert) that may increase metformin concentrations significantly;
Other illness
- Known neuropsychiatric disorders or serious psychiatric symptoms;
- Renal impairment (estimated glomerular filtration \< 60 mL/min/1.73m2);
- Hypersensitivity to metformin;
- Claustrophobia, metal implants or any other condition that prevents performing MR scan;
Lab values
- Type I or type II diabetes (fasting plasma glucose \>7mmol/L and/or HbA1c \>6.5%);
Other
- Known neurosyphilis;
- Known vitamin B12 deficiency;
- Significant head trauma with imaging structural abnormalities;
- Any contraindication or special precaution in the metformin package insert which may put the participant at a safety risk;
- Pregnant / breastfeeding;
Who the study is looking for
- 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);
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desmond Tutu Health Foundation: Gugulethu Research Site Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.