NCT07007221

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

Not yet recruiting Phase 2 Last updated 14 January 2026

What this trial tests

Phase 2 trial testing Metformin in Depression in 600 participants. Not yet recruiting.

Timeline

1 July 2026

Primary endpoint
1 December 2030

1 December 2030

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	600
Start date	1 July 2026
Primary completion	1 December 2030
Estimated completion	1 December 2030

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Metformin (metformin) — full drug profile →
• Metformin (metformin) — full drug profile →
• Placebo
• Metformin (metformin) — full drug profile →
• Fluoxetine (fluoxetine) — full drug profile →
• Metformin+Fluoxetine — full drug profile →
• double placebo

Conditions studied

• Depression — all drugs for Depression →
• Hiv — all drugs for Hiv →

Sponsor

University of Minnesota

Who can join

Adults 18 to 65, any sex, with Depression or Hiv. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.

Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.

Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.

Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.

Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.