Phase I Study of HIV 1 Antigen Expanded Specific T Cell Therapy (NCT02208167) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of HIV 1 Antigen Expanded Specific T Cell Therapy
United States6 participantsStarted 2015-04-07
Plain-language summary
This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in HIV-infected individuals with viral suppression on antiretroviral therapy (ART).
Who can participate
Age range
18 Years – 65 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
. ≥ 18 years and ≤65 years of age
. Confirmation of HIV 1 infection
. AHI participants are defined as HIV infected patients on suppressive ART that was initiated within 45 days of AHI diagnosis as defined in protocol section 5.1.2.
. CHI participants are defined as HIV infected patients who initiated ART with chronic HIV as defined in protocol section 5.1.2.
. On potent antiretroviral therapy, defined as at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor without interruption (defined as missing doses for more than two (2) consecutive days or more than four (4) cumulative days) in the 12 weeks prior to entry.
. Stable ART regimen for minimum of 3 months. NOTE: The ART regimen is defined by current treatment guidelines. Participants may have had one or more changes in their ART regimen for tolerance, change of guidelines, or dosing simplification.
. Ability and willingness of participant to continue cART throughout the study.
. Plasma HIV 1 RNA below detected limit by conventional assays (limit of detection: 75, 50, 40, or 20 copies/mL) for ˃1 year.
Exclusion criteria
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
Safety
Timeframe: 1st day of study treatment until 28 days post last infusion
. Prior use of any HIV immunotherapy or vaccine within 12 months prior to Screening.
. Use of any of the following within 90 days prior to entry: immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, IFN, interleukin 2 (IL 2), Coumadin, warfarin, or other Coumadin derivative anticoagulants.
. Received any infusion blood product, immune globulin, or hematopoietic growth factors within 90 days prior to study entry.
. Pregnancy or breast-feeding.
. History or other evidence of severe illness, malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the investigator.
. Use of topical steroids over a total area exceeding 0.5mg/kg/day within 30 days prior to Screening.
. Any active malignancy that may require chemotherapy or radiation therapy.
. Compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric illness or a physical illness, e.g., infectious disease. Prisoner recruitment and participation is not permitted.