2000HIV Trained Innate Immunity in HIV Elite Controllers (NCT04968717) | Clinical Trial Compass
CompletedNot Applicable
2000HIV Trained Innate Immunity in HIV Elite Controllers
Netherlands109 participantsStarted 2021-08-02
Plain-language summary
Some individuals are able to spontaneously control HIV replication, the so-called 'elite controllers' (ECs). ECs are crucial for our understanding of HIV infection. While there is more and more evidence pointing towards a role of the innate immune system in elite control, no research has been performed on the role of innate trained immunity in elite control of HIV.
In this cross-sectional case-control study, we will study this role of trained immunity in HIV elite control by comparing ECs both to a non-HIV-infected first-degree relative, and to HIV patients who are not elite controllers. In addition, we will study whether HIV itself can induce a trained innate immunity phenotype.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
All participants:
* All participants must be ≥18 years of age.
* Due to distorting effects on immune parameters and immune responses, participation is either not possible or must be delayed in case of the following:
* active hepatitis B/C or signs of acute infections
* active or recent malignant condition (i.e. \<12 months ago treated)
* active systemic auto-immune or auto-inflammatory conditions (such as rheumatoid arthritis, inflammatory bowel disease).
* use of immunosuppressive medication
* pregnant
HIV elite controllers:
HIV elite controllers in the 2000HIV that have an available first-degree relative. Definition of HIV elite controller is the same as in the 2000HIV, see definition on page 7 of the protocol and in the group description.
ART-suppressed people living with HIV:
As a control group, ART-suppressed people living with HIV in the 2000HIV that have an available first-degree relative will be included.
ART-suppressed people living with HIV need to apply to the following criteria to participate in the 2000HIV: ≥18 years, on cART ≥6 months with an HIV-RNA load \<200 copies/mL.
For this 2000HIV-trained study, additional criteria for ART-suppressed people living with HIV are:
* Never applied to controller definition.
* At least one documented HIV RNA load \>100.000 copies/mL
* No documentation of recent HIV acquisition combined with ART initiation in less than 6 months.
Eligible ART-suppressed people living with HIV will be matched by sex and age (m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.