GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide (Rybelsus®), Placebo.
- Who it may be relevant to
- Registry conditions: HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT
Overview
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 the average number of alcoholic beverages participants drink per week? 2. Does semaglutide lower the average number of cigarettes participants smoke per day? 3. Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco? Researchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week. Participants will: 1. Take semaglutide for 3 months 2. Visit the research clinic 3 times for checkups and tests 3. Provide blood samples, stool samples, and saliva samples for tests.
Interventions
- Drug Semaglutide (Rybelsus®)
experimental study medication - Drug Placebo
Placebo study product
Primary outcome measures
- Average drinks/week past 30 days at 3 months [Time frame: 3 Months]
Secondary outcome measures (2)
- Average cigarettes per day (cpd) past 30 days at 3 months [Time frame: 3 Months]
- Systemic inflammation (IL-6) at 3 months [Time frame: 6 Months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Known allergy to semaglutide
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07221214 · 1P60AA032176 · 1P60AA032176