Clinical Trial

Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Study acronym: META HIV CVD
Recruiting Phase 2
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Summary
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2022-03-10; most recent amendment 2025-06-18.
Status change: Not Yet Recruiting → Recruiting 2023-09-20
Trial Details
NCT Number NCT05288790
Lead Sponsor Vanderbilt University Medical Center
Collaborators: University of Louisville, Boston University
Conditions Microtia, Dysbiosis, Alcohol Drinking, HIV Infections, Cardiovascular Diseases
Enrollment 250 participants
Start Date 2023-09-18
Primary Completion 2026-08-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-06-24