Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: The Cleveland Cardiometabolic Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Body composition measures
研究概览
简要总结
In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.
详细描述
The effects of lifestyle factors on body composition changes after antiretroviral therapy (ART) are unknown, and as such, investigators will use this prospective observational cohort to study relationships between lifestyle factors, including diet, physical activity and illicit drug use, with changes in body composition after ART. In addition, the effect of the body fat changes will be correlated to changes in cardiometabolic indices such as endothelial function and coronary calcium scoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
- •Provides written informed consent and is capable of reading and comprehending the informed consent
- •Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped >6 months prior to study entry
- •Is planning on starting antiretroviral therapy as part of routine clinic care
排除标准
- •Pregnancy or lactation
研究组 & 干预措施
HIV-infected ART-naïve
HIV-infected subjects ≥ 16 years who are ART-naïve starting their first antiretroviral regimen
干预措施: Dual-energy X-ray absorptiometry (Diagnostic Test)
结局指标
主要结局
Body composition measures
时间窗: Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year
Assessed using DEXA (dual energy x-ray absorptiometry) scans which will be quantifying total body fat
次要结局
- endothelial function measures(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- calcium score measures(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- Metabolic syndrome(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- Resting Energy Expenditure (REE) measures(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- central obesity(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- Lipids measures(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
- Fasting plasma glucose measures(Baseline, 6-month, 1 year, 2 year, 3 year, 4 year, 5 year)
研究者
Grace McComsey
Principle Investigator
University Hospitals Cleveland Medical Center