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.
Study Type
OBSERVATIONAL
Enrollment
7
No investigational cell product will be administered
Georgetown University
Washington D.C., District of Columbia, United States
Washington Health Institute
Washington D.C., District of Columbia, United States
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
Time frame: 1year to 15years post infusion
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)
Time frame: 1year to 15 years
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