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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
Taylor Square Medical Practice
Monash Health
Albion Street Clinic
Information provided by (Responsible Party):
Kirby Institute

Tracking Information
First Submitted Date November 12, 2020
First Posted Date November 23, 2020
Last Update Posted Date November 23, 2020
Actual Study Start Date December 5, 2017
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2020)
Proportion of participants with at least one somatic mutation associated with clonal haematopoiesis [ Time Frame: 2017-2019 ]
Detection of mutations associated with clonal haematopoiesis
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 18, 2020)
  • Median and natural log-transformed Interleukin-6 [ Time Frame: 2017-2019 ]
    Interleukin-6 level
  • 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
  • Median (IQR) and natural log-transformed Haemoglobin [ Time Frame: 2017-2019 ]
    Haemoglobin
  • 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
  • natural log-transformed Mean corpuscular volume [ Time Frame: 2017-2019 ]
    mean corpuscular volume
  • natural log transformed Red Cell distribution width [ Time Frame: 2017-2019 ]
    red cell distribution width
  • Proportion of participants with diagnosed cardiovascular conditions, any malignancy, haematologic malignancies [ Time Frame: 2017-2019 ]
    Comorbid conditions
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People over the age of 55, with and without HIV
Condition
  • HIV Infections
  • Aging
Intervention Not Provided
Study Groups/Cohorts
  • People with HIV over the age of 55 years
  • People without HIV over the age of 55 years
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 18, 2020)
446
Original Actual Enrollment Same as current
Estimated Study Completion Date December 4, 2027
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04641013
Other Study ID Numbers 2020-11-ARCHIVE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Kirby Institute
Original Responsible Party Same as current
Current Study Sponsor Kirby Institute
Original Study Sponsor Same as current
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
Investigators
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
PRS Account Kirby Institute
Verification Date November 2020