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

NCT ID: NCT04888754

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2034-01-31

Brief Summary

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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

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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).

Conditions

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HIV Infections HIV-1-infection HIV-2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Casper Rokx

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Casper Rokx, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Tokameh Mahmoudi, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL72765.078.20

Identifier Type: -

Identifier Source: org_study_id

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