An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.
A Pilot Study to Evaluate Efficacy and Safety of Multiplexed shRNA-modified CD34+ Cells in HIV-infected Patients.
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
Started Feb 2018
Typical duration for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2018
CompletedFirst Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 19, 2020
February 1, 2020
2.8 years
March 20, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse side effects
Patients will be monitored for any signs of adverse effects.
18 months
Secondary Outcomes (1)
Efficacy of treatment
18 months
Study Arms (3)
No busulfan preconditioning
EXPERIMENTALshRNA-modified CD34+ cells without busulfan preconditioning.
Low dose busulfan preconditioning
EXPERIMENTALshRNA-modified CD34+ cells, with a single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
High dose busulfan preconditioning
EXPERIMENTALshRNA-modified CD34+ cells, with a single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) from 18 - 25; body weight ≥50kg.
- 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.
You may not qualify if:
- Existence of infections/opportunistic tumors.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Public Health Clinical Centerlead
- R&D Kanglin Biotechcollaborator
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hongzhou Lu, Ph.D
Caolang Road NO. 2901, Jinshan District, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 20, 2018
First Posted
May 7, 2018
Study Start
February 27, 2018
Primary Completion
December 15, 2020
Study Completion
December 31, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share