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NCT00842634 · ClinicalTrials.gov registry record · Phase 1
Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00842634: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT00842634 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00842634, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called "CD4 T-cells." Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS). In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent. The purpose of this research study is to find out whether "zinc finger" modified T-cells are 1. safe to give to humans and 2. find how "zinc finger" modified T cell affects HIV This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects). All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 mont
Interventions
- BIOLOGICAL ZFN modified T cells
- OTHER Structured Treatment Interruption
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-01 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00842634
The ClinicalTrials.gov registry entry for NCT00842634 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ZFN modified T cells is the first listed.
NCT00842634 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00842634 about?
NCT00842634 is a clinical study titled "Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV". This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into a...
What is the current status of trial NCT00842634?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00842634?
The interventions under investigation include: ZFN modified T cells (BIOLOGICAL), Structured Treatment Interruption (OTHER).
Who is sponsoring clinical trial NCT00842634?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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