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

Active, not recruiting

• Conditions: HIV Infections; HIV-2 Infection; HIV-1-infection

• Registration Number: NCT04888754
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-05-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2027-01
• Study Completion: 2034-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.	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.	5-10 years	The HIV reservoir will be characterised over time to study the dynamics of the reservoir

Secondary Outcome Measures

Name	Time	Method
To compare and validate new reservoir assays with current established assays.	5-10 years	Blood and leucapheresis samples will be collected to compare and validate new reservoir assays
To explore established and putative new interventions aimed at curing HIV.	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.	5-10 years	Blood and leucapheresis samples will be collected for reservoir characterisation to compare reservoirs between patients

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands