This is a pilot study of the infusion of haploidentical NK cells with IL-2 in 5 HIV+ individuals who are on stable ART with full HIV suppression.
Potential subjects will be screened to determine eligibility. Immediately after consent and screening, an HLA-haploidentical donor will be identified and will complete eligibility screen and consent. At Day -7 the subject will undergo an inguinal lymph node biopsy and colonoscopy to obtain ileal and rectal biopsies. Blood samples will be obtained to measure chimerisms, plasma HIV RNA, and inflammatory cytokines. PBMCs will be obtained to sort into CD4 subsets and measure frequencies of HIV RNA and DNA. On Day -1, the donor will undergo apheresis and donor cells will be obtained and incubated overnight with IL-2. On Day 0 subjects will start aspirin and be infused with IL-2 activated NK cells. Subjects will receive 6 million units of IL-2 just after the infusion and they will be monitored on the Phase 1 Unit for 24 hours. Plasma will be obtained at 2 hrs, 4 hrs and the following morning and stored for measures of inflammatory markers. The subject will return to the outpatient clinic on days 2, 4, 6, 8, and 10 after the infusion for administration of 6 million units of IL-2 and to obtain plasma and PBMC for measures of inflammatory markers and changes to the virus reservoir. On day 14 the subject will stop taking ASA and blood will be obtained to measure frequencies of HIV RNA and DNA. On day 21 will have a lymph node biopsy and colonoscopy to obtain ileal and rectal tissues. The patient will then be followed until day 100 post NK cell infusion. Subjects will return every 2 weeks for a toxicity assessment, blood draws, and viral level testing. Study participation will end after day 100.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Natural Killer Cells
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Safety of administration of haploidentical NK cells in HIV infected individuals - Adverse Events
Subjects will receive haploidentical NK and all adverse events will be collected
Time frame: Baseline, 100 days
Tolerability of administration of haploidentical NK cells in HIV infected individuals- Side effects
Side effects from all subjects will be collected
Time frame: Baseline, 100 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.