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| Name | Class |
|---|---|
| R&D Kanglin Biotech | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No busulfan preconditioning | Experimental | shRNA-modified CD34+ cells without busulfan preconditioning. |
|
| Low dose busulfan preconditioning | Experimental | shRNA-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 | Experimental | shRNA-modified CD34+ cells, with a single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shRNA-modified CD34+ cells | Biological | Infusion of CD34+ cells transduced with shRNAs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse side effects | Patients will be monitored for any signs of adverse effects. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment | Evaluate the efficacy of modified autologous CD34+ cells by monitoring CD4 counts and HIV-1 RNA level. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhou Lu, M.D., Ph.D | Contact | +86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
| Li Liu, M.D., Ph.D | Contact | 86-021-37990333 | 3222 | liulishaphc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongzhou Lu, Ph.D | Caolang Road NO. 2901, Jinshan District, Shanghai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 201508 | China |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Infusion of autologous CD34+ cells transduced with shRNAs targeting CCR5 and HIV genome
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| Low dose busulfan preconditioning | Drug | A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation. |
|
|
| Busulfan preconditioning | Drug | A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation. |
|
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |