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NCT00991224 · ClinicalTrials.gov registry record · Phase 1
Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy
A Phase 1 study of HIV Infections, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT00991224: Completed Phase 1 study of HIV Infections, sponsored by University of Pennsylvania.
NCT00991224 is a Phase 1 study of HIV Infections that has completed, run by University of Pennsylvania. The registered enrollment target is 2 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00991224, a Phase 1 study of HIV Infections, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is being carried out to study a new way to possibly treat HIV. T-cells are one of the white blood cells used by the body to fight HIV. CD8 T-cells are a type of T-cell used by the body to detect and kill cells which have been infected by foreign viruses or organisms, including the HIV virus. CD8 T-cells must identify the HIV virus in order to kill it. Because HIV is constantly changing the way it looks to the CD8 T-cells, some of the HIV virus escapes detection and is not killed by the CD8 T-cells. This research study uses a T cell receptor (TCR) protein specific for HIV (SL9 TCR) and adds it to the CD8 T-cells in the laboratory in order to help the CD8 T-cells recognize the constantly changing HIV virus and make it able to fight HIV more efficiently. TCR stands for T cell receptor. TCRs are found on the surface of T cells and allow the T cells to recognize other cells. Laboratory studies have shown that when CD8 T-cells are modified with SL9 TCRs, they kill cells that are infected with HIV better than normal CD8 T-cells can. On the basis of these laboratory results, there is the potential that SL9 TCRs may work in people infected with HIV and improve their immune system by killing HIV infected cells and thus may help control HIV infection. Two different SL9 TCRs will be tested in this study, WT-gag-TCR and α/6-gag-TCR. Two different types of SL9 TCRs are being used in this research study because the laboratory studies suggest that the different SL9 TCRs will function differently depending on the amount of virus in your body. A goal of this clinical study is to test the effects of infusions of either SL9 TCR in the presence or absence of a viral load. All subjects who receive WT-gag-TCR or the α/6-gag-TCR T cells will be enrolled in a Long Term Follow up study to monitor subjects. Subjects will be followed every 6 months for five years following the 1st infusion of the T cells. If the WT-gag-TCR or the α/6-gag-TCR T cells are no longer found i
Conditions Studied
Interventions
- BIOLOGICAL WT-gag-TCR modified T cells
- BIOLOGICAL α/6-gag-TCR modified T cells
- OTHER STI or Drug Holiday
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00991224
The ClinicalTrials.gov registry entry for NCT00991224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (100% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which WT-gag-TCR modified T cells is the first listed.
NCT00991224 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00991224 about?
NCT00991224 is a clinical study titled "Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy". This research study is being carried out to study a new way to possibly treat HIV. T-cells are one of the white blood cells used by the body to fight HIV. CD8 T-cells are a type of T-cell used by the body to detect and kill cells which have been infected by foreign viruses or organisms, including th...
What is the current status of trial NCT00991224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2009-11. Estimated completion is 2014-01.
What conditions does trial NCT00991224 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00991224?
The interventions under investigation include: WT-gag-TCR modified T cells (BIOLOGICAL), α/6-gag-TCR modified T cells (BIOLOGICAL), STI or Drug Holiday (OTHER).
Who is sponsoring clinical trial NCT00991224?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00991224 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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