Aging With HIV and Neurocognitive Decline, a Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 11
- 主要终点
- Proportion of patients with cognitive decline
研究概览
简要总结
The ANRS ( Agence Nationale de Recherches sur le Sida et les Hépatites virales) 0093s Aging HAND study is to assess whether PLHIV (People Living with HIV) initially between 55-70 years of age at baseline analysis under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up.
Aging HAND is a French, multicentric, longitudinal, transversal, prospective study with inclusion of 290 PLHIV.
详细描述
The primary objective of this study is to analyze whether PLHIV initially aged between 55-70 years of age at baseline under antiretroviral therapy have accelerated decline of neurocognitive function after 6 years of follow-up in comparison with an age, gender and educational level matched HIV non-exposed control group from the CONSTANCES cohort.
The secondary objectives of this study are :
- To determine the prevalence of neurocognitive impairment (NCI) according to the Frascati criteria, clinical consensus and alternative classifications, after additional accrual of individuals aged 55 to 76 years for a more precise and extensive age range analysis of NCI
- To describe the incidence and prevalence of the frailty syndromes, and their relation with co-morbidities and NCI, using the Fried score as a measure of frailty
- To constitute a plasma and serum biobank for biomarkers study related to the aging of PLHIV
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for PLHIV for the longitudinal study:
- •Having participated in the ANRS EP58 HAND 55-70 study
- •A signed informed consent
- •To be affiliated and benefit from the French Social Security
- •Inclusion criteria for PLHIV for the transversal study (only for new subjects):
- •Aged between 55 years and 76 years;
- •with a viral load < 50 copies/mL for more than 24 months (with a minimum of 3 available viral loads 6 months prior to inclusion). Blips -defined by a transient increase in viral load- are allowed if < 200 copies/mL, with a maximum of two blips within 24 months;
- •With a CD4 (cluster of differentiation 4) count at inclusion ≥ 200 cells/µL for more than the last 12 months (with a last available CD4 count < 6 months of inclusion);
- •A signed informed consent
- •To be affiliated and benefit from the French Social Security
排除标准
- •Non-inclusion criteria for PLHIV for both the longitudinal and transversal studies:
- •An Isolated HIV-2 infection
- •Confused or with an ongoing neurological disease
- •Presenting psychiatric syndromes interfering with cognitive evaluation;
- •With sensorial loss, analphabetism or language barriers rendering the interpretation of tests difficult.
- •With recent extensive neurocognitive evaluation within 6 months prior to inclusion
- •With neurological disease with ongoing clinically relevant sequela
- •Participating in another research program, prohibiting the participating in additional research
- •Vulnerable: minors, under guardianship or curatorship, or persons deprived of liberty for administrative or judiciary reasons
研究组 & 干预措施
Single arm
290 PLHIV, aged 55 to 76 years old
干预措施: cognitive functional assessment (Other)
结局指标
主要结局
Proportion of patients with cognitive decline
时间窗: 12 months
The global cognitive decline of patients, expressed through the mean Z-score (with higher scores indicating better cognition) using the mean of z scores of the 5 following cognitive tests (NPZ 5 score): Trail Making Test A-B (TMT A-B), Digit Symbol Substitution Task (DSST) of the WAIS-IV (Wechsler Adult Intelligence Scale), digital finger tapping test, word fluency and formal lexical and semantic evocation for language, Free and Cued Selective Reminding Test.
次要结局
- Proportion of patients with NCI(12 months)
- Incidence and prevalence of frailty(12 months)
- Description of the causes of NCI confirmed(12 months)