Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04641013

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Study type

Observational

Primary location

St Vincent's Hospital HIV, Immunology and Infectious Disease Unit, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis

    Time frame: 2017-2019

    Detection of mutations associated with clonal haematopoiesis

Secondary outcomes

  1. Median and natural log-transformed Interleukin-6

    Time frame: 2017-2019

    Interleukin-6 level

  2. Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27

    Time frame: 2017-2019

    C-reactive protein, Cystatin C, D-dimer

  3. Median (IQR) and natural log-transformed Haemoglobin

    Time frame: 2017-2019

    Haemoglobin

  4. 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

    Time frame: 2017-2019

    White blood cell count, Neutrophil count, Lymphocyte count, platelet count

  5. natural log-transformed Mean corpuscular volume

    Time frame: 2017-2019

    mean corpuscular volume

  6. natural log transformed Red Cell distribution width

    Time frame: 2017-2019

    red cell distribution width

  7. Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies

    Time frame: 2017-2019

    Comorbid conditions

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Albion Street Clinic
  • East Sydney Doctors
  • Holdsworth House Medical Centre
  • Monash Health
  • Peter MacCallum Cancer Centre, Australia
  • Prahran Market Clinic
  • RPA Sexual Health
  • St Vincent's Hospital
  • Taylor Square Medical Practice
  • The Alfred

Registry information

Official study title

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

Acronym: ARCHIVE

Important dates

Study start
2017
Primary completion
2019
Study completion
2027
First posted
Nov 23, 2020
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.