A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T

American Gene Technologies International Inc.

Summary

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.

Description

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial 2. Provided written informed consent, signed and dated by the study participant in the long-term follow-up study Exclusion Criteria: 1\. Did not receive the investigational product, AGT103-T

Interventions

Biological
Gene modified therapy
No investigational cell product will be administered

Locations (2)

Georgetown University
Washington D.C., District of Columbia
Washington Health Institute
Washington D.C., District of Columbia