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

NCT ID: NCT04641013

Last Updated: 2020-11-23

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-05

Study Completion Date

2027-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

Holdsworth House Medical Centre

UNKNOWN

Sponsor Role collaborator

Prahran Market Clinic

UNKNOWN

Sponsor Role collaborator

East Sydney Doctors

UNKNOWN

Sponsor Role collaborator

RPA Sexual Health

UNKNOWN

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

St Vincent's Hospital

OTHER

Sponsor Role collaborator

Taylor Square Medical Practice

UNKNOWN

Sponsor Role collaborator

Monash Health

OTHER

Sponsor Role collaborator

Albion Street Clinic

UNKNOWN

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Albion Street Centre

Sydney, New South Wales, Australia

Site Status

East Sydney Doctors

Sydney, New South Wales, Australia

Site Status

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Site Status

Kirby Institute

Sydney, New South Wales, Australia

Site Status

Taylor Square Private Clinic

Sydney, New South Wales, Australia

Site Status

RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown

Sydney, New South Wales, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Prahran Market Clinic

Melbourne, Victoria, Australia

Site Status

Monash Medical Centre

Melbourne, Victoria, Australia

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

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.

Reference Type DERIVED
PMID: 34099923 (View on PubMed)

Other Identifiers

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2020-11-ARCHIVE

Identifier Type: -

Identifier Source: org_study_id