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An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy

HIV Clinical Trial

Official title:
An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact and Durability of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy(ART) in Participants With Human Immunodeficiency Virus(HIV) Previously Treated With AGT103-T

Clinical Trial Summary

To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.

Clinical Trial Description

Study subjects who have been infused with AGT103-T in a prior trial (AGT-HC-168) will be invited to stop their antiretroviral therapy in two phases. The first antiretroviral interruption will be closely monitored and if at any point study termination criteria are met, the study participant will be placed back on antiretroviral therapy. The second antiretroviral therapy will be instituted once the inclusion criteria are met. The aim of two antiretroviral interruptions is to allow for adequate sensitization of the cells and expansion of the pool of infused gene-modified cells. The two-phased ATI allows for a more robust suppression of HIV in study participants. Participants are monitored closely to determine if the autologous T cells with which they were previously infused, modify the kinetics of HIV rebound. The study participant will be closely monitored for the recurrence of HIV viremia and a decrease in their CD4 lymphocyte number. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05540964
Study type Observational
Source American Gene Technologies International Inc.
Contact
Status Enrolling by invitation
Phase
Start date July 19, 2022
Completion date July 19, 2025
View Details
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