2000HIV Trained Innate Immunity in HIV elite controllers

2000HIV Trained Innate Immunity in HIV elite controllers - 2000HIV-Trained

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50913

Enrollment

120

Registered

2021-06-09

Start date

2021-08-02

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All participants/first degree relatives: 1. All participants must be *18 years of age. HIV elite controllers: 1. Participation in 2000HIV study 2. Available first-degree relative 3. Meet criteria of elite controller (see protocol page 7 for elaborate definition) ART-suppressed people with HIV: 1. On cART *6 months with an HIV-RNA load 100.000 copies/mL 4. No documentation of recent HIV acquisition combined with ART initiation in less than 6 months 5. Available first-degree relative

Exclusion criteria

Exclusion criteria: All participants: 1. Active hepatitis B/C or signs of acute infections 2. Active or recent malignant condition (i.e.

Design outcomes

Primary

Measure	Time frame
Main study endpoints 1. Innate immune training indices: o Direct cytokine responses to a range of stimuli o Cytokine responses after 6-day training with Beta-glucan	—

Secondary

Measure	Time frame
Secundary study parameters: 1. Transcriptome signatures of innate immune training (including long non-coding RNA patterns) 2. Epigenetic signatures of innate immune training 3. Differentially expressed genes on a transcriptomic level that are associated with HIV elite controller phenotype or their family members. 4. Specific populations of circulating cells, identified by immune phenotyping, that can differentiate between HIV elite controller phenotype and ART-suppressed people with HIV, or their respective family members.	—

Measure

Time frame

Secundary study parameters: 1. Transcriptome signatures of innate immune training (including long non-coding RNA patterns) 2. Epigenetic signatures of innate immune training 3. Differentially expressed genes on a transcriptomic level that are associated with HIV elite controller phenotype or their family members. 4. Specific populations of circulating cells, identified by immune phenotyping, that can differentiate between HIV elite controller phenotype and ART-suppressed people with HIV, or their respective family members.

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Countries

Netherlands

Outcome results