Health TrialsbyHealthPanel

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

ConditionsHIVAlcoholSmoking CigaretteCardiovascular Disease Prevention
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide (Rybelsus®)

    Drug

    experimental study medication

  • Placebo

    Drug

    Placebo study product

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Average drinks/week past 30 days at 3 months

Average drinks/week past 30 days (via Timeline Follow Back (TLFB))

Time frame
3 Months

Secondary outcomes

1

Average cigarettes per day (cpd) past 30 days at 3 months

Average cigarettes per day in the past 30 days (via TLFB)

Time frame
3 Months
2

Systemic inflammation (IL-6) at 3 months

Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Norton Healthcare

Collaborator

University of Louisville

Collaborator

Source ClinicalTrials.gov
Apply now