HIV, Alcohol, Smoking Cigarette, Cardiovascular Disease Prevention
Conditions
Keywords
HIV, alcohol, smoking, tobacco, cardiovascular disease
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 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
experimental study medication
DRUGPlacebo
Placebo study product
Sponsors
Vanderbilt University Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Norton Healthcare
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average drinks/week past 30 days at 3 months | 3 Months | Average drinks/week past 30 days (via Timeline Follow Back (TLFB)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average cigarettes per day (cpd) past 30 days at 3 months | 3 Months | Average cigarettes per day in the past 30 days (via TLFB) |
| Systemic inflammation (IL-6) at 3 months | 6 Months | Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk |
Contacts
CONTACTHilary A Tindle, MD, MPH
CONTACTRachel Jones, MS
PRINCIPAL_INVESTIGATORHilary A Tindle, MD, MPH
Vanderbilt University Medical Center
Outcome results
None listed