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:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT04281459
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 chronic infection;
* therapy with three-drugs and standard dosage ART containing rilpivirine: either rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey) or rilpivirine/lamivudine/abacavir;
* virological suppression (VL\<50 copies/ml) for at least 12 months before switching to SCT. One viral blip with VL\<200 copies/ml, followed by a second deterrmination after 30 days \<20 copies/ml is admitted;
* CD4+ cells count \>200/mmc;
* no evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; no history of previous failures with their ART regimens;
* ability to provide written informed consent.
Exclusion Criteria:
* evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; history of previous failures with their ART regimen;
* diagnosis of any opportunistic infection in the 2 weeks before enrollment;
* for women, ongoing pregnancy and lactation;
* history of HBV infection (positive anti-HBc antibodies, with negative anti-HBs antibodies);
* therapy with experimental drugs/chemotherapy/radiotherapy in the 12 weeks before enrolment;
* current abuse of drugs or alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04281459
Study Brief:
Protocol Section:
NCT04281459