2000HIV Trained Innate Immunity in HIV elite controllers

Completed

Conditions: HIV
10027665
10047438

Registration Number: NL-OMON50913

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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 <200 copies/mL
2. Never applied to controller definition.
3. At least one documented 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

All participants:
1. Active hepatitis B/C or signs of acute infections
2. Active or recent malignant condition (i.e. <12 months ago treated)
3. Active systemic auto-immune or auto-inflammatory conditions (such as
rheumatoid arthritis, inflammatory bowel disease).
4. Use of immunosuppressive medication
5. Pregnant

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoints<br /><br>1. Innate immune training indices:<br /><br>o Direct cytokine responses to a range of stimuli<br /><br>o Cytokine responses after 6-day training with Beta-glucan</p><br>

Secondary Outcome Measures

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