A Pilot Study of Metformin to Reduce Cerebrovascular Dysfunction in Participants With HIV and Metabolic Syndrome.

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Stellenbosch
• Collaborators: Fogarty International Center of the National Institute of Health; University of Rochester
• Treatments: Metformin

Criteria

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);

• Reactive hyperemia (RH) peripheral arterial tonometry (PAT) index < 1.67 dysfunction).

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%);

• Receiving treatment with a statin for hypercholesterolaemia;

• 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;