An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.
NCT ID: NCT03517631
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2018-02-27
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No busulfan preconditioning
shRNA-modified CD34+ cells without busulfan preconditioning.
shRNA-modified CD34+ cells
Infusion of CD34+ cells transduced with shRNAs.
Low dose busulfan preconditioning
shRNA-modified CD34+ cells, with a single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
shRNA-modified CD34+ cells
Infusion of CD34+ cells transduced with shRNAs.
Low dose busulfan preconditioning
A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
High dose busulfan preconditioning
shRNA-modified CD34+ cells, with a single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
shRNA-modified CD34+ cells
Infusion of CD34+ cells transduced with shRNAs.
Busulfan preconditioning
A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
Interventions
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shRNA-modified CD34+ cells
Infusion of CD34+ cells transduced with shRNAs.
Low dose busulfan preconditioning
A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
Busulfan preconditioning
A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of HIV infections/AIDS based on "Diagnostic Criteria for HIV/AIDS" WS 293-2008.
* No antiretroviral therapy (ART) in the past 6 weeks and refuse to receive ART.
* CD4 T cell count ≥350/μl.
* No plan for pregnancy in the near future and agree to practice non-drug based contraception.
* Voluntary to participate in the study, comply with the study design to complete all monitory measurements, and agree to sign the study agreement.
Exclusion Criteria
* Mutations in the shRNA target sequences.
* White blood cell count \<3x10\^9/L, neutrophil count \<1.5x10\^9/L, hemoglobin \<110g/L, platelet count \<100x10\^9/L.
* Liver diseases (HBV, chronic HCV infection, congenital liver metabolic disease), abnormal liver functions (test value 2x above normal).
* Kidney deficiency (Creatinine level above the upper limit of normal levels).
* Severe chronic disease, metabolic disease (e.g., diabetes), neurological and psychiatric diseases.
* History of pancreatitis.
* Women in pregnancy, lactating or at reproductive age who do not practice contraception.
* Allergy to agents or drugs used in the study.
* Verified or suspected abuse of alcohol and drugs.
* Participated in other clinical trials within 3 months.
* Based on investigator's assessment, those who are unfit for the study (e.g., general weakness, poor compliance with study design).
* Personal or family history of tumors.
18 Years
50 Years
ALL
No
Sponsors
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R&D Kanglin Biotech
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
Responsible Party
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Hongzhou Lu
professor
Principal Investigators
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Hongzhou Lu, Ph.D
Role: STUDY_DIRECTOR
Caolang Road NO. 2901, Jinshan District, Shanghai
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KL1702
Identifier Type: -
Identifier Source: org_study_id
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