Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Desmond Tutu Health Foundation: Gugulethu Research Site
Coordinator of this site? Confirm its status
Cape TownSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.