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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05220358
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected men or women
* Aged 18-65
* Stable insurance plan
* Documented plasma HIV-1 RNA \< 50 c/mL x 2 within the last year prior to screening
* Must be on a stable ARV regimen for ≥6 months prior to screening
* CD4+T-cell count\<350 cells/mm3 while on ARVs for at least 2 years
* Must be willing to add FTR 600 mg twice daily to their current antiretroviral regimen
* Must have attended ≥ 2 clinic visits in the 12 months prior to screening
Exclusion Criteria:
* Newly or recently diagnosed HIV-1 infection defined as HIV-1 infection diagnosed in the prior 6 months
* Active HBV or HCV co-infection
* Unstable liver disease or Child-Pugh C liver disease
* History of autoimmune disease
* History of any malignancy ≤5 years
* History of radiation or cytotoxic chemotherapy
* Use of systemic corticosteroids or other immunomodulatory agents in the last 14 days prior to study entry
* Confirmed QT value \> 500 msec at Screening or Day 1 or confirmed QTcF value \> 470 msec for women and \> 450 msec for men at Screening or Day 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05220358
Study Brief:
Protocol Section:
NCT05220358