Effects of Tirzepatide on Weight Loss and Chronic Inflammation in People With HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Baseline Body Weight
研究概览
简要总结
This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •HIV-1 infection (well controlled)
- •Documented HIV-1 infection ≥ 1 year prior to study entry (ELISA confirmed by Western blot or HIV-1 RNA) AND
- •HIV-1 RNA <200 copies/mL for ≥ 6 months
- •· Receiving a stable antiretroviral regimen for at least 1 year prior to study entry
- •BMI ≥27 kg/m2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) OR Obese
- •BMI ≥ 30 kg/m2
排除标准
- 未提供
研究组 & 干预措施
Tirzepatide
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change in Baseline Body Weight
时间窗: 12 weeks
The primary outcome will be the change in baseline body weight (measured in lbs) at 12 weeks.
次要结局
- Change in Inflammatory Markers: TNF-α(12 weeks)
- Change in Inflammatory Markers: NFkB(12 weeks)
- Change in Inflammatory Markers: sCD163, and sCD14(12 weeks)
- Change in Inflammatory Markers: GM-CSF(12 weeks)
- Change in cardiometabolic markers(12 weeks)
- Monocyte Subset Analysis(Week 12 and week 16)
- Change in Inflammatory Markers: IFN-γ(12 weeks)
- Change in Inflammatory Markers: IL-1β(12 weeks)
- Change in Inflammatory Markers: IL-2(12 weeks)
- Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10(12 weeks)
- Change in Inflammatory Markers: GM-CSF(12 weeks)
- Change in cardiometabolic markers(12 weeks)
- Monocyte Subset Analysis(Week 12 and week 16)
- Change in Inflammatory Markers: IFN-γ(12 weeks)
- Change in Inflammatory Markers: IL-1β(12 weeks)
- Change in Inflammatory Markers: IL-2(12 weeks)
- Change in Inflammatory Markers: IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10(12 weeks)
- Change in Inflammatory Markers: TNF-α(12 weeks)
- Change in Inflammatory Markers: NFkB(12 weeks)
- Change in Inflammatory Markers: sCD163, and sCD14(12 weeks)
- Body composition(12 weeks)
- Waist circumference(12 weeks)
- Liver fat content(12 weeks)
- Liver stiffness measurement (LSM)(12 weeks)
研究者
Christine Akamine
Assistant Professor
University of Hawaii