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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Aging

• Study Type: Observational
• Enrollment (Actual): 446

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Sydney, New South Wales, Australia, 2010
      • Taylor Square Private Clinic
    • Sydney, New South Wales, Australia, 2010
      • Albion Street Centre
    • Sydney, New South Wales, Australia, 2010
      • East Sydney Doctors
    • Sydney, New South Wales, Australia, 2010
      • Kirby Institute
    • Sydney, New South Wales, Australia, 2050
      • RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Melbourne, Victoria, Australia, 3141
      • Prahran Market Clinic
    • Melbourne, Victoria, Australia
      • Peter Maccallum Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

People over the age of 55, with and without HIV

Description

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
People with HIV over the age of 55 years
People without HIV over the age of 55 years

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: The Alfred; Peter MacCallum Cancer Centre, Australia; St Vincent's Hospital; Monash Health; Holdsworth House Medical Centre; Prahran Market Clinic; East Sydney Doctors; RPA Sexual Health; Taylor Square Medical Practice; Albion Street Clinic
• Investigators: Principal Investigator: Mark Polizzotto, MBBS, PhD, Kirby Institute, UNSW Sydney; Principal Investigator: Nila Dharan, MD, Kirby Institute, UNSW Sydney; Principal Investigator: Kathy Petoumenos, PhD, Kirby Institute, UNSW Sydney

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2017
• Primary Completion (ACTUAL): April 17, 2019
• Study Completion (ANTICIPATED): December 4, 2027

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 2020-11-ARCHIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No