Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)
- Conditions
- HIV InfectionsAging
- Registration Number
- NCT04641013
- Lead Sponsor
- Kirby Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Not specified
- Target Recruitment
- 446
- 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
- Unwilling or unable to provide consent to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis 2017-2019 Detection of mutations associated with clonal haematopoiesis
- Secondary Outcome Measures
Name Time Method Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27 2017-2019 C-reactive protein, Cystatin C, D-dimer
Median (IQR) and natural log-transformed Haemoglobin 2017-2019 Haemoglobin
Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies 2017-2019 Comorbid conditions
Median and natural log-transformed Interleukin-6 2017-2019 Interleukin-6 level
natural log-transformed Mean corpuscular volume 2017-2019 mean corpuscular volume
natural log transformed Red Cell distribution width 2017-2019 red cell distribution width
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 White blood cell count, Neutrophil count, Lymphocyte count, platelet count
Trial Locations
- Locations (11)
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
Albion Street Centre
🇦🇺Sydney, New South Wales, Australia
East Sydney Doctors
🇦🇺Sydney, New South Wales, Australia
Kirby Institute
🇦🇺Sydney, New South Wales, Australia
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
🇦🇺Sydney, New South Wales, Australia
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
🇦🇺Darlinghurst, New South Wales, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Taylor Square Private Clinic
🇦🇺Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Prahran Market Clinic
🇦🇺Melbourne, Victoria, Australia