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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

446

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach

1 country

11 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 years study duration

Study Progress84%

Dec 2017Dec 2027

Study Start

First participant enrolled

December 5, 2017

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed

1.6 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed

11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed

7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2027

Expected

Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

November 12, 2020

Last Update Submit

November 18, 2020

Conditions

HIV Infections Aging

Outcome Measures

Primary Outcomes (1)

Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
Detection of mutations associated with clonal haematopoiesis
2017-2019

Secondary Outcomes (7)

Median and natural log-transformed Interleukin-6
2017-2019
Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27
2017-2019
Median (IQR) and natural log-transformed Haemoglobin
2017-2019
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
2017-2019
natural log-transformed Mean corpuscular volume
2017-2019
+2 more secondary outcomes

Study Arms (2)

People with HIV over the age of 55 years

People without HIV over the age of 55 years

Eligibility Criteria

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

People over the age of 55, with and without HIV

You may qualify if:

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

You may not qualify if:

\- Unwilling or unable to provide consent to participate

Contact the study team to confirm eligibility.

Study Sites (11)

St Vincent's Hospital HIV, Immunology and Infectious Disease Unit

Darlinghurst, New South Wales, 2010, Australia

Location

Albion Street Centre