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Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Study acronym: META HIV CVD
StatusRecruiting
PhasePhase 2
Started2023-09-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 28, 2026 → Mar 31, 2027
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-08-26
Study Status v15
Primary completion pushed: 2026-08-28 → 2027-03-31
Completion pushed: 2027-02-28 → 2027-08-31
2025-06-18
Study Status v14
Primary completion date2026-02-28→2026-08-28
Completion date2026-08-31→2027-02-28
2024-06-27
Study Status v13
Primary completion date2026-03-31→2026-02-28
2024-05-15
Study Status, Contacts/Locations v12
Re-verified, no change to tracked fields
2023-09-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v11
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05-31→2026-03-31
Start dateestimated 2023-08-31→confirmed 2023-09-18
Show 10 earlier versions
2023-08-04
Study Status v10
Start date2023-08-01→2023-08-31
2023-08-01
Study Status v9
Re-verified, no change to tracked fields
2023-07-05
Study Status v8
Start date2023-07-01→2023-08-01
2023-06-05
Study Status v7
Start date2023-04-30→2023-07-01
2023-04-03
Study Status v6
Start date2023-02-28→2023-04-30
2022-12-09
Study Status v5
Start date2022-11-01→2023-02-28
2022-10-11
Study Status, Study Design v4
PhasePhase 2/3→Phase 2
2022-07-01
Study Status, Study Design, Arms and Interventions v3
PhaseNot applicable→Phase 2/3
Primary completion date2025-10→2026-05-31
Completion date2026-08→2026-08-31
Start date2022-10→2022-11-01
2022-06-30
Study Status, Eligibility v2
Primary completion date2025-06→2025-10
Start date2022-06→2022-10
Eligibility criteriarevised
Inclusion Criteria: HIV infected Exclusion Criteria: Not fluent in RussianEnglish
2022-03-21
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2022-03-10
Original filing
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.
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 2027-03-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-27