Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)

Study Overview
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Brief Summary
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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.

Official Title
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Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study

Conditions
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HIV Infections, Aging

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Medicine14. 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 Exclusion Criteria: - Unwilling or unable to provide consent to participate

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People with HIV over the age of 55 years<br> | |
| People without HIV over the age of 55 years<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis | Detection of mutations associated with clonal haematopoiesis | 2017-2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median and natural log-transformed Interleukin-6 | Interleukin-6 level | 2017-2019 | 
| Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27 | C-reactive protein, Cystatin C, D-dimer | 2017-2019 | 
| Median (IQR) and natural log-transformed Haemoglobin | Haemoglobin | 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 | White blood cell count, Neutrophil count, Lymphocyte count, platelet count | 2017-2019 | 
| natural log-transformed Mean corpuscular volume | mean corpuscular volume | 2017-2019 | 
| natural log transformed Red Cell distribution width | red cell distribution width | 2017-2019 | 
| Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies | Comorbid conditions | 2017-2019 |