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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03215004
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged between ≥18 and ≤60 years
* Documented HIV infection for at least 3 years prior to study entry
* Stable on HIV antiretroviral regimen with viral suppression to \<50c/mL plasma for \>2 years
* Agrees not to change antiretroviral regimen (unless medically indicated) during the study period
* CD4+ T cell count \>500 cell per millimeter cubed (cells/mm3) at last measurement within 6 months of study participation
* CD4+ T cell nadir of \>350 cells/mm3
* HIV plasma viral load \<50 copies of viral RNA per milliliter (mL) for \>2 years
* Participants who had intermittent, isolated episodes of detectable low-level viremia (\<500c/mL; blips) will remain eligible.
* Have not received cytoreduction therapy within 3 months of study entry
* Do not have prior events of hemorrhagic cystitis
* Is not being treated or does not have bacteremia within the past 6 months
* Does not have signs or symptoms of acute infectious disease
* Adequate venous access and no other contraindications for leukapheresis
* Hematocrit is \>33% or hemoglobin is ≥13g/dL (males) and ≥12g/dL (females) at last measurement within 7 days prior to study enrollment; test also required within 3 days prior to leukapheresis
* Weighs more than 75 lbs
* Not pregnant at time of enrollment
* Ability to understand the study and must be willing to comply with study-required procedures and visits, including only changing antiretroviral regimen when indicated by the study doctor during the study period
* Written informed consent signed and dated by study participant
Exclusion Criteria:
* Acute or chronic hepatitis B or hepatitis C infection with detectable viremia
* Any viral hepatitis or liver disease (e.g. cirrhosis)
* Active or recent (prior 6 months) AIDS defining complication
* Any experimental HIV medications within the past 12 weeks
* Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
* Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
* Any clinically significant renal, hepatic, and pulmonary disease
* Inadequate venous access or contraindicated for leukapheresis
* Significant laboratory values and/or a chronic medical condition that, in the opinion of the Principal Investigator, could impact trial participation
* Receiving another investigational drug or device within 30 days of study entry
* Previously received any gene transfer therapy
* History or any features on physical examination indicative of a bleeding diathesis
* Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to screening (NOTE: Use of inhaled or topical steroids is not exclusionary)
* Breast-feeding or pregnant
* Use of aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis
* Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
* Recent vaccination or intercurrent illness within 5 weeks prior to T cell infusion (NOTE: It is recommended that participants should have completed their routine vaccinations, e.g. hepatitis A or B, pneumococcus, influenza and tetanus diphtheria booster, at least 30 days prior to screening for the study)
* Asplenia: any conditions resulting in the absence of a functional spleen
* History of hereditary angioedema, acquired angioedema or idiopathic angioedema
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03215004
Study Brief:
Protocol Section:
NCT03215004