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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

• Study Contact: Name: Casper Rokx, MD PhD; Phone Number: 0681336328; Email: c.rokx@erasmusmc.nl
• Study Contact Backup: Name: Tokameh Mahmoudi, PhD; Email: t.mahmoudi@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.	The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow	5-10 years
To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.	The HIV reservoir will be characterised over time to study the dynamics of the reservoir	5-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To explore established and putative new interventions aimed at curing HIV.	Blood and leucapheresis samples will be collected for testing of HIV cure drugs	5-10 years
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.	Blood and leucapheresis samples will be collected for reservoir characterisation to compare reservoirs between patients	5-10 years
To compare and validate new reservoir assays with current established assays.	Blood and leucapheresis samples will be collected to compare and validate new reservoir assays	5-10 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Casper Rokx, MD PhD, Erasmus Medical Center; Principal Investigator: Tokameh Mahmoudi, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; HIV cure; HIV reservoir
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: NL72765.078.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No definitive decision on this yet. This will also depend on confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No