CD4 CAR+ ZFN-modified T Cells in HIV Therapy (NCT03617198) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CD4 CAR+ ZFN-modified T Cells in HIV Therapy
United States12 participantsStarted 2019-07-31
Plain-language summary
This research study is being carried out to study a new way to possibly treat HIV. As part of this study, doctors will take some of your own white blood cells, called T-cells, and modify them so that they can identify and target your HIV cells. The purpose of the study is to evaluate the safety of these modified T cells and determine whether they have any effect on HIV infection.
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.
Inclusion Criteria:
* HIV-1 infection
* Clinically stable on first or second HAART regimen
* Screening CD4+ T cell count of ≥450 cells/mm3 within 30 days of enrollment; and a documented CD4 nadir of not lower than 200 cells/mm3
* Screening HIV-1 RNA that is ≤50 copies/mL within 30 days prior to enrollment
* HIV-1 RNA ≤50 copies/mL for at least 24 weeks prior to enrollment
* Adequate venous access and no other contraindications for leukapheresis
* Laboratory values within certain parameters, obtained within 30 days prior to enrollment
* Willing to comply with study-mandated evaluations
* Male or female, 18 years of age or older
* Ability and willingness to provide informed consent
* Karnofsky Performance Score of 70 or higher
* Negative HBsAg (hepatitis B) within 6 months prior to enrollment
* Negative HCV (hepatitis C) serology, or if positive, negative HCV RNA within 6 months prior to enrollment
* Have a recorded viral load set point prior to starting antiretroviral therapy
Exclusion Criteria:
* Acute or chronic hepatitis B or hepatitis C infection
* Current or prior AIDS diagnosis
* History of cancer or malignancy, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
* History or any features on physical examination indicative of active or unstable cardiac disease or hemodynamic instability (subjects with a history of cardiac disease may participate with a physician's approval)
* History or any features of physical examination indi…
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.
What they're measuring
1
Number of subjects with treatment related adverse events.
Timeframe: After subjects have received infusion and up to 5 years from Day 0 infusion.