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A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands (CHRONO)

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ClinicalTrials.gov Identifier: NCT04888754
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Casper Rokx, Erasmus Medical Center

Brief Summary:
A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.

Condition or disease
HIV Infections HIV-1-infection HIV-2 Infection

Detailed Description:

HIV cannot be cured with the current treatment armamentarium. A reservoir of latently HIV infected long lived CD4+T-cells is present in patients with HIV that are not affected by antiretroviral therapy. The evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. This study aims to anticipate on future HIV cure strategies by building a cohort to study ex vivo the reservoirs of HIV patients, the obstacles to cure HIV, and new therapeutic compounds and strategies.

Main study parameters/endpoints:

  1. Change in viral reservoir size after antiretroviral treatment initiation.
  2. Evolution of phenotypical and functional aspects of the anti-HIV host immune responses.
  3. Ex vivo activity of established and novel HIV latency reversing agents.
  4. Variance in HIV reservoir and host immunity between HIV subtypes and clinical variables.

A project from the Erasmus MC HIV Eradication Group (EHEG).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions. [ Time Frame: 5-10 years ]
    The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow

  2. To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy. [ Time Frame: 5-10 years ]
    The HIV reservoir will be characterised over time to study the dynamics of the reservoir


Secondary Outcome Measures :
  1. To explore established and putative new interventions aimed at curing HIV. [ Time Frame: 5-10 years ]
    Blood and leucapheresis samples will be collected for testing of HIV cure drugs

  2. To explore differences in reservoir size, activity and host responses, and their relation with clinical characteristics, between patients with different dominant HIV subtypes and sexes. [ Time Frame: 5-10 years ]
    Blood and leucapheresis samples will be collected for reservoir characterisation to compare reservoirs between patients

  3. To compare and validate new reservoir assays with current established assays. [ Time Frame: 5-10 years ]
    Blood and leucapheresis samples will be collected to compare and validate new reservoir assays


Biospecimen Retention:   Samples With DNA
Blood samples and leucapheresis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are 18 years or older with a confirmed HIV infection without prior exposure to cART (treatment naïve). Prior use of pre-exposure prophylaxis is allowed.
Criteria

Inclusion Criteria:

  • Age >18 years.
  • Confirmed HIV-1 or HIV-2 infection
  • Judged willing to initiate and adhere to cART by the HIV physician.

Exclusion Criteria:

  • Inability to place venous catheters to draw blood.
  • Major comorbidities:

    1. Severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction).
    2. The inability to participate due to any other relevant social, environmental,psychological, factors or according to the HIV treating physician's judgement.

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): NCT04888754


Contacts
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Contact: Casper Rokx, MD PhD 0681336328 c.rokx@erasmusmc.nl
Contact: Tokameh Mahmoudi, PhD t.mahmoudi@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CN
Contact: Casper Rokx, MD PhD    +31681336328    c.rokx@erasmusmc.nl   
Sub-Investigator: Jeroen van Kampen, MD PhD         
Sub-Investigator: Yvonne Muller, PhD         
Sub-Investigator: Tokameh Mahmoudi, PhD         
Sub-Investigator: Charles Boucher, MD PhD         
Sub-Investigator: David Burger, PHD         
Sub-Investigator: Rob Gruters, PhD         
Sub-Investigator: Kathryn Hensley, MD         
Sub-Investigator: Peter Katsikis, Prof         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Casper Rokx, MD PhD Erasmus MC
Principal Investigator: Tokameh Mahmoudi, PhD Erasmus MC
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Responsible Party: Casper Rokx, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04888754    
Other Study ID Numbers: NL72765.078.20
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No definitive decision on this yet. This will also depend on confidentiality.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Casper Rokx, Erasmus Medical Center:
HIV
HIV cure
HIV reservoir
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes