Clinical trial NCT04888754: A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands
Official title: A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
HIV-1-infection
HIV-2 Infection
Keywords: HIV
HIV cure
HIV reservoir
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.
timeFrame: 5-10 years
measure: To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.
timeFrame: 5-10 years
Secondary outcomes:
measure: To explore established and putative new interventions aimed at curing HIV.
timeFrame: 5-10 years
measure: 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.
timeFrame: 5-10 years
measure: To compare and validate new reservoir assays with current established assays.
timeFrame: 5-10 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Casper Rokx, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Tokameh Mahmoudi, PhD
role: PRINCIPAL_INVESTIGATOR
References: