NCT07221214招募中2 期
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV - GL1DER HIV RCT
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Average drinks/week past 30 days at 3 months
研究概览
简要总结
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:
- Does semaglutide lower the average number of alcoholic beverages participants drink per week?
- Does semaglutide lower the average number of cigarettes participants smoke per day?
- 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:
- Take semaglutide for 3 months
- Visit the research clinic 3 times for checkups and tests
- Provide blood samples, stool samples, and saliva samples for tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Semaglutide
Experimental
drug intervention
干预措施: Semaglutide (Rybelsus®) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Average drinks/week past 30 days at 3 months
时间窗: 3 Months
Average drinks/week past 30 days (via Timeline Follow Back (TLFB))
次要结局
- Average cigarettes per day (cpd) past 30 days at 3 months(3 Months)
- Systemic inflammation (IL-6) at 3 months(6 Months)
研究者
Hilary Tindle
Professor of Medicine
Vanderbilt University Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)NCT07218354VA Office of Research and Development622
已完成
2 期
Semaglutide Therapy for Alcohol Reduction - TulsaAlcohol Use DisorderNCT05891587Oklahoma State University Center for Health Sciences80
招募中
2 期
GLP-1R Agonist Treatment for Opioid Use DisorderOpioid Use DisorderOpioid Abuse and AddictionNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersOpioidMental DisorderNCT06548490Milton S. Hershey Medical Center200
尚未招募
2 期
Semaglutide in Auto-HSCTIntestinal MucositisInflammationChemotherapeutic ToxicityNCT06449625Klaus Gottlob Müller40
已完成
4 期
Semaglutide in Nonalcoholic Fatty Liver DiseaseNon-alcoholic Fatty Liver DiseaseNCT05813249Zagazig University180