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NCT05215704Recruiting

Ex Vivo Characterization and Targeting of the Latent HIV Infected Reservoir to Cure HIV

Source: ClinicalTrials.gov · Last updated 14 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Combination antiretroviral therapy (cART) blocks intracellular human immunodeficiency virus (HIV) replication in CD4+ T-lymphocytes, but fails to eliminate latent HIV infected CD4+ T-lymphocytes. About 7 (range \<1-100) in 106 of these cells are latently infected and can cause reactivation of proviral HIV when cART is stopped. These latently infected cells form the reservoir and must be targeted in order to cure HIV. We would like to further investigate this reservoir and assess potential interventions to eradicate it. One promising option is to further study the influence of HIV latency disruptors (latency reversing agents, LRA) on the HIV infected reservoir. These agents are used in shock and kill strategies that disrupt latency by LRA followed by the selective (induced) killing of the reservoir cell due to viro-pathogenic effects. For accurate assessment of the reservoir and potential cure strategies, including the impact of LRA on the reservoir, a large reservoir and sufficient cells for analysis are desirable. Our understanding on the reservoir comes from in vitro lymphocyte models and early ex vivo studies. Additional studies of patients with different clinical phenotypes including untreated versus treated versus the rare individuals that control HIV spontaneously are increasingly relevant to the field. Especially this last category represent biological examples of viral control without cART and are useful to study the factors that set them apart from those that need treatment for their HIV. This study aims to deepen our understanding of the HIV reservoir and cure strategies, foremost, shock and kill strategies. We will do this by setting up a durable ex vivo platform for HIV reservoir and cure studies of which the samples can be used for hypothesis generation for in-vivo studies. A project from the Erasmus MC HIV Eradication Group (EHEG).

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
15 Dec 2021
Start date
1 Jan 2012
Primary completion date
31 Dec 2030
Lead sponsor
Erasmus Medical Center
Diseases
HIV
NCT number
NCT05215704

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 1 Jan 2012 to the primary completion date, 31 Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Major comorbidities:
    • Severe symptomatic anemia B. Recent symptomatic cardiovascular event (unstable angina pectoris, decompensated heart failure, myocardial infarction).
  • The inability to participate due to any other relevant medical, social, environmental, psychological, factors or according to the HIV treating physician's judgement

Other

  • Inability to place 2.5 cm venous catheter or perform phlebotomy

Who the study is looking for

  • Age 18 years or older.
  • Confirmed HIV-1 or HIV-2 infection.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Erasmus Medical Centre
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.