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NCT Number: NCT04888754

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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:

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project

Acronym: CHRONO

Important dates

Study start
2021
Primary completion
2027
Study completion
2034
First posted
May 17, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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