Status:
NOT_YET_RECRUITING
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Norton Healthcare
Conditions:
HIV
Alcohol
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are: 1. Does semaglutide lower th...
Eligibility Criteria
Inclusion
- Ages 18-89
- Prior diagnosis of HIV-1
- Affiliated with Vanderbilt Comprehensive Care Clinic
- On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.
- Most recent absolute CD4 count ≥ 300 cells/mm3 and drawn within 12 months of study enrollment
- BMI ≥ 23 (calculated at screening)
- Self-report of consuming alcohol in past 90 days
- AUDIT-C ≥ 3 (male)/ ≥ 2 (female)
- Has an established stable address at which they can receive mail and can be reached for the next 6 months
- Willing and able to complete study procedures and follow-ups
Exclusion
- Known allergy to semaglutdie
- Currently taking GLP-1 RA (in the past 3 months)
- History of diabetes defined by diagnosis in Problems List in medical record
- History of pancreatitis
- History of gastroparesis
- Gallbladder disease (in the past 3 months)
- History of medullary thyroid carcinoma
- Family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia syndrome type 2
- Family history of multiple endocrine neoplasia syndrome type 2
- Cognitive inability to consent
- Barrier to speaking, hearing, reading, or writing English
- Pregnant or breastfeeding, or planning to become pregnant in the next 6 months
- Too ill to complete study procedures
Key Trial Info
Start Date :
February 6 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07221214
Start Date
February 6 2026
End Date
July 31 2030
Last Update
November 12 2025
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