A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands (CHRONO)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04888754|
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : July 28, 2022
|Condition or disease|
|HIV Infections HIV-1-infection HIV-2 Infection|
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).
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
- 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
- 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
- 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
- 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
- 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
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
|Contact: Casper Rokx, MD PhDemail@example.com|
|Contact: Tokameh Mahmoudi, PhDfirstname.lastname@example.org|
|Rotterdam, Netherlands, 3015 CN|
|Contact: Casper Rokx, MD PhD +31681336328 email@example.com|
|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|
|Principal Investigator:||Casper Rokx, MD PhD||Erasmus MC|
|Principal Investigator:||Tokameh Mahmoudi, PhD||Erasmus MC|