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

Kirby Institute

Status: Active, not recruiting

Conditions: Aging; HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT04641013

2020-11-ARCHIVE

Details and patient eligibility

About

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.

Enrollment: 446 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

446 participants in 2 patient groups

People with HIV over the age of 55 years

People without HIV over the age of 55 years