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临床试验/NCT03268109
NCT03268109已完成不适用

COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2017年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
281
试验地点
1
主要终点
cognitive impairment

研究概览

简要总结

Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Personal or familial cognitive complaints
  • Individual aged ≥ 65 years old and < 81 years old
  • Instrumental activities of daily living (IADL) score between 3-4
  • French speaking individual
  • Informed consent signed For PLHIV
  • HIV infection
  • Undetectable HIV viral load ≥ 1 year
  • Current cluster of differentiation (CD4) cell count > 100/mm3 For controls
  • negative HIV serology ≤ 6 months

排除标准

  • Opportunistic infection < 5 years
  • Contraindications to MRI

结局指标

主要结局

cognitive impairment

时间窗: baseline

cognitive impairment frequency, defined by a z-score ≤ 1.65 in at least 2 cognitive domains

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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