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An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.

NCT03517631 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-19

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • AIDS

Interventions

BIOLOGICAL

shRNA-modified CD34+ cells

Infusion of CD34+ cells transduced with shRNAs.

DRUG

Low dose busulfan preconditioning

A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.

DRUG

Busulfan preconditioning

A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.

Sponsors & Collaborators

  • R&D Kanglin Biotech

    collaborator OTHER

  • Shanghai Public Health Clinical Center

    lead OTHER_GOV

Principal Investigators

  • Hongzhou Lu, Ph.D · Caolang Road NO. 2901, Jinshan District, Shanghai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2020-12-15
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517631 on ClinicalTrials.gov