Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)
NCT ID: NCT04641013
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
446 participants
OBSERVATIONAL
2017-12-05
2027-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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People with HIV over the age of 55 years
No interventions assigned to this group
People without HIV over the age of 55 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
No
Sponsors
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Peter MacCallum Cancer Centre, Australia
OTHER
Holdsworth House Medical Centre
UNKNOWN
Prahran Market Clinic
UNKNOWN
East Sydney Doctors
UNKNOWN
RPA Sexual Health
UNKNOWN
The Alfred
OTHER
St Vincent's Hospital
OTHER
Taylor Square Medical Practice
UNKNOWN
Monash Health
OTHER
Albion Street Clinic
UNKNOWN
Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Mark Polizzotto, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute, UNSW Sydney
Nila Dharan, MD
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute, UNSW Sydney
Kathy Petoumenos, PhD
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute, UNSW Sydney
Locations
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St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
Darlinghurst, New South Wales, Australia
Albion Street Centre
Sydney, New South Wales, Australia
East Sydney Doctors
Sydney, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Kirby Institute
Sydney, New South Wales, Australia
Taylor Square Private Clinic
Sydney, New South Wales, Australia
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Prahran Market Clinic
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Countries
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References
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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.
Other Identifiers
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2020-11-ARCHIVE
Identifier Type: -
Identifier Source: org_study_id