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Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.
The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene modified therapy | Biological | No investigational cell product will be administered |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incidence of delayed adverse events (AE) to gene therapy | The presence of malignancies, incidence or exacerbation of pre-existing neurologic disorder, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, the new incidence of a hematologic disorder post infusion with AGT103T | 1year to 15years post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The persistence and the immunity impact of the vector-modified T cells | Evaluate sustained impact on immunity measured by CD4 T cell responses to Gag peptides Measure proportion of participants with absence of replication competent lentivirus (RCL) Measure persistence of vector-modified cells (transgene copies per CD4 T cell) | 1year to 15 years |
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Inclusion Criteria:
Exclusion Criteria:
1. Did not receive the investigational product, AGT103-T
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Subject who received the investigational product AGT103-T in the AGT-HC168 clinical trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States | ||
| Washington Health Institute |
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Blood
| Washington D.C. |
| District of Columbia |
| 20017 |
| United States |