Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT06252402
Eligibility Criteria:
Inclusion Criteria:
* Participant must be ≥ 18 years of age at the time of screening;
* Karnofsky Performance Status (KPS) ≥ 70;
* Documented HIV-1 infection anytime prior to study entry.;
* On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable);
* CD4+ cell count ≥ 450 cells/μL;
* Adequate organ function;
* Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
* Not pregnant or breastfeeding.
Exclusion Criteria:
* Concurrent illness or comorbid condition;
* History of resistance to two or more classes of antiretroviral drugs;
* History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06252402
Study Brief:
Protocol Section:
NCT06252402