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

HIV Infections Clinical Trial

— ARCHIVE  

Official title:

Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04641013
• Other study ID #: 2020-11-ARCHIVE
• Status: Active, not recruiting
• Start date: December 5, 2017
• Est. completion date: December 4, 2027

Study information

• Verified date: November 2020
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The objectives of the study are to evaluate genomic and other factors associated with aging, stratified by HIV status.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 446
• Est. completion date: December 4, 2027
• Est. primary completion date: April 17, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• HIV Infections

Locations

Country	Name	City	State
Australia	St Vincent's Hospital HIV, Immunology and Infectious Disease Unit	Darlinghurst	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Prahran Market Clinic	Melbourne	Victoria
Australia	Albion Street Centre	Sydney	New South Wales
Australia	East Sydney Doctors	Sydney	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Kirby Institute	Sydney	New South Wales
Australia	RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown	Sydney	New South Wales
Australia	Taylor Square Private Clinic	Sydney	New South Wales

Sponsors (11)

Lead Sponsor	Collaborator
Kirby Institute	Albion Street Clinic, East Sydney Doctors, Holdsworth House Medical Centre, Monash Health, Peter MacCallum Cancer Centre, Australia, Prahran Market Clinic, RPA Sexual Health, St. Vincent's Hospital-Manhattan, Taylor Square Medical Practice, The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis	Detection of mutations associated with clonal haematopoiesis	2017-2019
Secondary	Median and natural log-transformed Interleukin-6	Interleukin-6 level	2017-2019
Secondary	Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27	C-reactive protein, Cystatin C, D-dimer	2017-2019
Secondary	Median (IQR) and natural log-transformed Haemoglobin	Haemoglobin	2017-2019
Secondary	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	2017-2019
Secondary	natural log-transformed Mean corpuscular volume	mean corpuscular volume	2017-2019
Secondary	natural log transformed Red Cell distribution width	red cell distribution width	2017-2019
Secondary	Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies	Comorbid conditions	2017-2019