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

Erasmus University

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT04888754

NL72765.078.20

Details and patient eligibility

About

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.

Full 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).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.