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

HIV Infections Clinical Trial

— CHRONO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04888754
• Other study ID #: NL72765.078.20
• Status: Active, not recruiting
• Start date: May 26, 2021
• Est. completion date: January 2034

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: January 2034
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• HIV-2 Infection
• Infections

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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