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New treatment option for HIV
Official title GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV
ClinicalTrials.gov ID: NCT07221214
What this study is testing
What is Semaglutide (Rybelsus®)?
Semaglutide (Rybelsus®) is an investigational medicine, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.