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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04641013




Registration number
NCT04641013
Ethics application status
Date submitted
12/11/2020
Date registered
23/11/2020
Date last updated
23/11/2020

Titles & IDs
Public title
Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)
Scientific title
Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
Secondary ID [1] 0 0
2020-11-ARCHIVE
Universal Trial Number (UTN)
Trial acronym
ARCHIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Aging 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People with HIV over the age of 55 years -

People without HIV over the age of 55 years -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis
Timepoint [1] 0 0
2017-2019
Secondary outcome [1] 0 0
Median and natural log-transformed Interleukin-6
Timepoint [1] 0 0
2017-2019
Secondary outcome [2] 0 0
Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27
Timepoint [2] 0 0
2017-2019
Secondary outcome [3] 0 0
Median (IQR) and natural log-transformed Haemoglobin
Timepoint [3] 0 0
2017-2019
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
2017-2019
Secondary outcome [5] 0 0
natural log-transformed Mean corpuscular volume
Timepoint [5] 0 0
2017-2019
Secondary outcome [6] 0 0
natural log transformed Red Cell distribution width
Timepoint [6] 0 0
2017-2019
Secondary outcome [7] 0 0
Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies
Timepoint [7] 0 0
2017-2019

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unwilling or unable to provide consent to participate

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/12/2027
Actual
Sample size
Target
Accrual to date
Final
446
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit - Darlinghurst
Recruitment hospital [2] 0 0
Albion Street Centre - Sydney
Recruitment hospital [3] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
Kirby Institute - Sydney
Recruitment hospital [6] 0 0
Taylor Square Private Clinic - Sydney
Recruitment hospital [7] 0 0
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown - Sydney
Recruitment hospital [8] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [10] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3141 - Melbourne
Recruitment postcode(s) [6] 0 0
3168 - Melbourne
Recruitment postcode(s) [7] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Holdsworth House Medical Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Prahran Market Clinic
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
East Sydney Doctors
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
RPA Sexual Health
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The Alfred
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
St Vincent's Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Taylor Square Medical Practice
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Monash Health
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Albion Street Clinic
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04641013
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Mark Polizzotto, MBBS, PhD
Address 0 0
Kirby Institute, UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04641013