The purpose of the study is to evaluate the efficacy and safety of autologous CD34+ cells that stably express multiplexed shRNA to treat HIV infection.
CD34+ cells will be isolated from mobilized PBMC of HIV patients. The cells will be lentivirally transduced with multiplexed shRNAs in the same vector that target CCR5 and HIV genome. Such modified cells will be infused back to the patients who have received bulsufan preconditioning before infusion. The patients will then be evaluated for efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Infusion of CD34+ cells transduced with shRNAs.
A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse side effects
Patients will be monitored for any signs of adverse effects.
Time frame: 18 months
Efficacy of treatment
Evaluate the efficacy of modified autologous CD34+ cells by monitoring CD4 counts and HIV-1 RNA level.
Time frame: 18 months
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