Clinical trial NCT04641013: Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)
Official title: Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Aging
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Peter MacCallum Cancer Centre, Australia
name: Holdsworth House Medical Centre
name: Prahran Market Clinic
name: East Sydney Doctors
name: RPA Sexual Health
name: The Alfred
name: St Vincent's Hospital
name: Taylor Square Medical Practice
name: Monash Health
name: Albion Street Clinic
First posted: 2020-11-23
Enrollment: 446
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People over the age of 55, with and without HIV

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
timeFrame: 2017-2019
Secondary outcomes:
measure: Median and natural log-transformed Interleukin-6
timeFrame: 2017-2019
measure: Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27
timeFrame: 2017-2019
measure: Median (IQR) and natural log-transformed Haemoglobin
timeFrame: 2017-2019
measure: 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
timeFrame: 2017-2019
measure: natural log-transformed Mean corpuscular volume
timeFrame: 2017-2019
measure: natural log transformed Red Cell distribution width
timeFrame: 2017-2019
measure: Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies
timeFrame: 2017-2019
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
state: New South Wales
city: Sydney
country: Australia
facility: Albion Street Centre
state: New South Wales
city: Sydney
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Kirby Institute
state: New South Wales
city: Sydney
country: Australia
facility: Taylor Square Private Clinic
state: New South Wales
city: Sydney
country: Australia
facility: RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Kirby Institute, UNSW Sydney
name: Mark Polizzotto, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirby Institute, UNSW Sydney
name: Nila Dharan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirby Institute, UNSW Sydney
name: Kathy Petoumenos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dharan NJ, Yeh P, Bloch M, Yeung MM, Baker D, Guinto J, Roth N, Ftouni S, Ognenovska K, Smith D, Hoy JF, Woolley I, Pell C, Templeton DJ, Fraser N, Rose N, Hutchinson J, Petoumenos K, Dawson SJ, Polizzotto MN, Dawson MA; ARCHIVE Study Group. HIV is associated with an increased risk of age-related clonal hematopoiesis among older adults. Nat Med. 2021 Jun;27(6):1006-1011. doi: 10.1038/s41591-021-01357-y. Epub 2021 Jun 7.