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Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy

NCT00991224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-10-10

No results posted yet for this 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 in the blood after five years, then subjects will be contacted yearly for the next 10 years. If the WT-gag-TCR or the α/6-gag-TCR T cells are found in the blood at five years after the 1st infusion of T cells, then the subjects will continue to be seen once a year until the WT-gag-TCR or the α/6-gag-TCR T cells are no longer found in the blood for a maximum of 15 years.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

WT-gag-TCR modified T cells

Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days.

BIOLOGICAL

α/6-gag-TCR modified T cells

Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days.

OTHER

STI or Drug Holiday

Subjects will stop taking antiviral medications for 16 weeks.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-01-31
Completion
2014-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00991224 on ClinicalTrials.gov