HIV InfectionsARCHIVENCT04641013
Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)
An observational study of HIV Infections and Aging, run by Kirby Institute at 11 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Aging
- How many people
- 446 participants
- Where
- 11 sitesAustralia
- Study dates
- 5 Dec 2017to 4 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: People over the age of 55, with and without HIV
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide consent to participate
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Australia11 sites
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
Darlinghurst, New South Wales, 2010
Alfred Hospital
Melbourne, Victoria, 3004
Prahran Market Clinic
Melbourne, Victoria, 3141
Monash Medical Centre
Melbourne, Victoria, 3168
Peter MacCallum Cancer Centre
Melbourne, Victoria
Albion Street Centre
Sydney, New South Wales, 2010
East Sydney Doctors
Sydney, New South Wales, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Kirby Institute
Sydney, New South Wales, 2010
Taylor Square Private Clinic
Sydney, New South Wales, 2010
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
Sydney, New South Wales, 2050
About this study
Official title: Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
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.
- Conditions
- HIV Infections, Aging
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with HIV over the age of 55 years | Not described | |
| People without HIV over the age of 55 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
Detection of mutations associated with clonal haematopoiesis
Measured: 2017-2019
Secondary outcomes (7)
Median and natural log-transformed Interleukin-6
Interleukin-6 level
Measured: 2017-2019
Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27
C-reactive protein, Cystatin C, D-dimer
Measured: 2017-2019
Median (IQR) and natural log-transformed Haemoglobin
Haemoglobin
Measured: 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
White blood cell count, Neutrophil count, Lymphocyte count, platelet count
Measured: 2017-2019
natural log-transformed Mean corpuscular volume
mean corpuscular volume
Measured: 2017-2019
natural log transformed Red Cell distribution width
red cell distribution width
Measured: 2017-2019
Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies
Comorbid conditions
Measured: 2017-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start5 Dec 2017
- Primary completion17 Apr 2019
- Study completion4 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Peter MacCallum Cancer Centre, Australia, Holdsworth House Medical Centre, Prahran Market Clinic, East Sydney Doctors, RPA Sexual Health, The Alfred, St Vincent's Hospital, Taylor Square Medical Practice, Monash Health, Albion Street Clinic
- Responsible party
- Sponsor
- Investigators
- Mark Polizzotto, MBBS, PhD, Principal investigator, Kirby Institute, UNSW SydneyNila Dharan, MD, Principal investigator, Kirby Institute, UNSW SydneyKathy Petoumenos, PhD, Principal investigator, Kirby Institute, UNSW Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641013
- Sponsor's protocol ID
- 2020-11-ARCHIVE
- Acronym
- ARCHIVE
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han WM, Sazzad HMS, Bloch M, Baker DA, Roth N, Bowden-Reid E, Smith DE, Hoy JF, Woolley I, Finlayson R, Templeton DJ, Matthews GV, Costello J, Dawson MA, Dawson SJ, Polizzotto MN, Petoumenos K, Yeh P, Dharan NJ; ARCHIVE Study Group. Age-related clonal hematopoiesis and HIV infection are associated with geriatric outcomes: The ARCHIVE study. Cell Rep Med. 2024 Dec 17;5(12):101835. doi: 10.1016/j.xcrm.2024.101835. Epub 2024 Dec 2.
PubMed 39626674Dharan 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.
PubMed 34099923
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
- ClinicalTrials.gov ID
- NCT04641013
- Acronym / sponsor ID
- ARCHIVE / 2020-11-ARCHIVE
- Conditions
- HIV Infections, Aging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Peter MacCallum Cancer Centre, Australia, Holdsworth House Medical Centre, Prahran Market Clinic, East Sydney Doctors, RPA Sexual Health, The Alfred, St Vincent's Hospital, Taylor Square Medical Practice, Monash Health, Albion Street Clinic
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 4 Dec 2027 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with HIV over the age of 55 years | – | – |
| People without HIV over the age of 55 years | – | – |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- People over the age of 55, with and without HIV
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
Time frame: 2017-2019
Detection of mutations associated with clonal haematopoiesis
7 secondary outcomes
Median and natural log-transformed Interleukin-6
Time frame: 2017-2019
Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27
Time frame: 2017-2019
Median (IQR) and natural log-transformed Haemoglobin
Time frame: 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
Time frame: 2017-2019
natural log-transformed Mean corpuscular volume
Time frame: 2017-2019
natural log transformed Red Cell distribution width
Time frame: 2017-2019
Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies
Time frame: 2017-2019
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Derived from this study: PubMed 39626674Han WM, Sazzad HMS, Bloch M, Baker DA, Roth N, Bowden-Reid E, Smith DE, Hoy JF, Woolley I, Finlayson R, Templeton DJ, Matthews GV, Costello J, Dawson MA, Dawson SJ, Polizzotto MN, Petoumenos K, Yeh P, Dharan NJ; ARCHIVE Study Group. Age-related clonal hematopoiesis and HIV infection are associated with geriatric outcomes: The ARCHIVE study. Cell Rep Med. 2024 Dec 17;5(12):101835. doi: 10.1016/j.xcrm.2024.101835. Epub 2024 Dec 2.
- Derived from this study: PubMed 34099923Dharan 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.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Polizzotto, MBBS, PhD principal investigator
Kirby Institute, UNSW Sydney
Nila Dharan, MD principal investigator
Kirby Institute, UNSW Sydney
Kathy Petoumenos, PhD principal investigator
Kirby Institute, UNSW Sydney
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Aging, run by Kirby Institute at 11 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis (time frame: 2017-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.