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临床试验/NCT04067219
NCT04067219终止不适用

Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients

University Hospital, Bordeaux0 个研究点目标入组 123 人开始时间: 2012年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
123
主要终点
Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters

研究概览

简要总结

this study consists of the study of markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

详细描述

Nowadays, the elevated frequency of cancers as well as cardiovascular, neurocognitive and bone diseases seems to denote a process of accelerated aging in the treated HIV-infected population of western countries, who are 40 to 50 years old in median. Markers of age-related alterations should be compared to the distribution among the general population whenever possible, to disentangle the effect of HIV and "normal" ageing or ageing due to other conditions. Common mechanisms should be better understood, more specifically those related to the impact of tobacco, antiretroviral treatments, and nutritional components. For markers of skin, muscle, neurocognitive function and bone ageing, the distribution of the general population is available and, in addition, alteration of these markers might have common mechanisms, such as insufficiency in 25 hydroxy vitamin D or nutritional parameters. Therefore, a joint study of these three organs seems particularly relevant.

This aim is to study markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • HIV-1 infected patients included in the TISSOS-VIH substudy of the ARNS CO3 Aquitaine Cohort or who had a DXA measurement of the lumbar spine, femoral neck, and total body between 2004 and 2011 at the University Hospital of Bordeaux,
  • > 18 years
  • Affiliated to the medical insurance
  • Having had at least one DXA measurement prior to the SIMBAD study visit
  • Written informed consent for the SIMBAD study

排除标准

  • Hepatitis C virus co-infection
  • Pregnancy

研究组 & 干预措施

Single arm

Experimental

HIV-1 infected patients

干预措施: DXA (dual-energy x-ray absorptiometric) measurement (Procedure)

结局指标

主要结局

Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters

时间窗: At the earliest at the inclusion visit and within a 9-month window after inclusion

presence of osteoporosis or osteopenia on DXA (T-score \< -2.5 and \<-1, respectively), locomotor test results \> 2 standard deviations of the mean of the general population, presence of premature hair whitening in patients aged \< 40 years (defined by\>50% of gray hair before the age of 40)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

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