Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV

Launched by UNIVERSITY OF MINNESOTA · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of Metformin, a medication commonly used to treat diabetes, as a potential treatment for depression in people living with HIV. Depression is a serious issue that affects many individuals with HIV and can make it harder for them to stick to their HIV treatment, which is crucial for their health and preventing the spread of the virus. The trial will take place in three parts: first, it will test different doses of Metformin to see how well they are tolerated; next, it will compare Metformin to a placebo (a pill with no active medication) to evaluate its effectiveness; and finally, it will look at how Metformin works alongside another antidepressant, fluoxetine, to see which treatment works better.

To participate in this trial, individuals must be between 18 and 65 years old, be HIV positive, and have been on HIV treatment for at least six months with undetectable viral levels. They must also have moderate to severe depression, confirmed through specific questionnaires. Participants can expect to be randomly assigned to receive either Metformin or a placebo and will be monitored over the course of 12 weeks. This trial aims to improve the understanding of how to better treat depression in people with HIV, ultimately helping them lead healthier lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-65 years old
• • HIV positive
• • On HIV antiretroviral therapy for \> 6 months
• • Undetectable HIV RNA
• • Outpatient
• • Depression by PHQ-9 \>10, confirmed by MADRS score 20+ and MINI interview
• • Provision of Informed Consent
• • Willingness to comply with all screening and study procedures
• • Primary Residence \<50 km from clinic
• Exclusion Criteria:
• • Planning to move out of clinic catchment area in the next 3 months
• • Suicidal (PHQ-9 question 9 score \>2) or MADRS item 10 with score of 4+
• • Pregnant or breastfeeding
• • Treatment with a rifamycin
• • Current use of any antidepressant, metformin, rifampicin, efavirenz, insulin, or sulfonylurea.
• • Active illicit drug use
• • Bipolar or psychotic disorder
• • Known cirrhosis or heart failure
• • Glomerular Filtration Rate (GFR) \<45
• • Abnormal TSH \>3.5 IU/mL
• • Previous Enrollment in the trial (Parts 2 and 3)