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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641013
Recruitment Status : Active, not recruiting
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
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-Manhattan
Taylor Square Medical Practice
Monash Health
Albion Street Clinic
Information provided by (Responsible Party):
Kirby Institute

Study Description
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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.

Condition or disease
HIV Infections Aging

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 446 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE): a follow-on Study of the Australian Positive & Peers Longevity Evaluation Study
Actual Study Start Date : December 5, 2017
Actual Primary Completion Date : April 17, 2019
Estimated Study Completion Date : December 4, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
People with HIV over the age of 55 years
People without HIV over the age of 55 years


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis [ Time Frame: 2017-2019 ]
    Detection of mutations associated with clonal haematopoiesis


Secondary Outcome Measures :
  1. Median and natural log-transformed Interleukin-6 [ Time Frame: 2017-2019 ]
    Interleukin-6 level

  2. Median (IQR) and natural log-transformed C-reactive protein and Cystatin C; D-dimer >0.27 [ Time Frame: 2017-2019 ]
    C-reactive protein, Cystatin C, D-dimer

  3. Median (IQR) and natural log-transformed Haemoglobin [ Time Frame: 2017-2019 ]
    Haemoglobin

  4. 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 ]
    White blood cell count, Neutrophil count, Lymphocyte count, platelet count

  5. natural log-transformed Mean corpuscular volume [ Time Frame: 2017-2019 ]
    mean corpuscular volume

  6. natural log transformed Red Cell distribution width [ Time Frame: 2017-2019 ]
    red cell distribution width

  7. Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies [ Time Frame: 2017-2019 ]
    Comorbid conditions


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
People over the age of 55, with and without HIV
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641013


Locations
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Australia, New South Wales
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
Darlinghurst, New South Wales, Australia, 2010
Albion Street Centre
Sydney, New South Wales, Australia, 2010
East Sydney Doctors
Sydney, New South Wales, Australia, 2010
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Kirby Institute
Sydney, New South Wales, Australia, 2010
Taylor Square Private Clinic
Sydney, New South Wales, Australia, 2010
RPA Sexual Health, Royal Prince Alfred Hospital, Camperdown
Sydney, New South Wales, Australia, 2050
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Prahran Market Clinic
Melbourne, Victoria, Australia, 3141
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sponsors and Collaborators
Kirby Institute
Peter MacCallum Cancer Centre, Australia
Holdsworth House Medical Centre
Prahran Market Clinic
East Sydney Doctors
RPA Sexual Health
The Alfred
St. Vincent's Hospital-Manhattan
Taylor Square Medical Practice
Monash Health
Albion Street Clinic
Investigators
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Principal Investigator: Mark Polizzotto, MBBS, PhD Kirby Institute, UNSW Sydney
Principal Investigator: Nila Dharan, MD Kirby Institute, UNSW Sydney
Principal Investigator: Kathy Petoumenos, PhD Kirby Institute, UNSW Sydney
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT04641013    
Other Study ID Numbers: 2020-11-ARCHIVE
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases