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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04641013
Acronym
ARCHIVE
Enrollment
446
Registered
2020-11-23
Start date
2017-12-05
Completion date
2027-12-04
Last updated
2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, HIV Infections

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis2017-2019Detection of mutations associated with clonal haematopoiesis

Secondary

MeasureTime frameDescription
Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.272017-2019C-reactive protein, Cystatin C, D-dimer
Median (IQR) and natural log-transformed Haemoglobin2017-2019Haemoglobin
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 count2017-2019White blood cell count, Neutrophil count, Lymphocyte count, platelet count
Median and natural log-transformed Interleukin-62017-2019Interleukin-6 level
natural log transformed Red Cell distribution width2017-2019red cell distribution width
Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies2017-2019Comorbid conditions
natural log-transformed Mean corpuscular volume2017-2019mean corpuscular volume

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026