NCT04641013进行中（未招募）不适用
Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 446
- 试验地点
- 11
- 主要终点
- Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
研究概览
简要总结
The ARCHIVE study is an observational longitudinal cohort study of people with and without HIV who are over the age of 55. The duration of the study is planned for 10 years, with study visits every 1-2 years. The objectives of the study are to evaluate genomic and other factors associated with aging, stratified by HIV status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •Men and women aged >55
- •For participants without HIV: an HIV negative test within 12 months prior to enrolment. If no HIV-negative test result is available within 12 months prior to enrolment, then participants will be tested for HIV as part of standard of care, if indicated by the guidelines for HIV testing published by the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine
- •This study will not conduct HIV testing; therefore, any participants without HIV being considered for participation in the study will need to have had a standard of care HIV negative test within the past 12 months. Some subjects at on-going risk for HIV are recommended to have periodic HIV testing and may be due for such testing as part of standard of care, at the time of enrolment into the study.
- •Willing and able to provide written informed consent and willingness to participate in and comply with a longitudinal cohort study including 1) consent to providing blood samples for full blood count, inflammatory marker testing and genomics analysis 2) consent to linking their data to national and state-wide data registries (including consent to providing personally identifying information); and 3) consent to participate in future follow-up studies
排除标准
- •Unwilling or unable to provide consent to participate
结局指标
主要结局
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
时间窗: 2017-2019
Detection of mutations associated with clonal haematopoiesis
次要结局
- natural log-transformed Mean corpuscular volume(2017-2019)
- natural log transformed Red Cell distribution width(2017-2019)
- Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27(2017-2019)
- Median (IQR) and natural log-transformed Haemoglobin(2017-2019)
- Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies(2017-2019)
- Median and natural log-transformed Interleukin-6(2017-2019)
- Median (IQR) and natural log-transformed White blood cell count, Median (IQR) and natural log-transformed Neutrophil count, natural log-transformed Lymphocyte count, natural log-transformed platelet count(2017-2019)
研究者
研究点 (11)
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