An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT05540964|
Recruitment Status : Enrolling by invitation
First Posted : September 15, 2022
Last Update Posted : September 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Antiretroviral Therapy Interruption(ATI)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All study participant that consent to the study will be withdrawn from their Antiretroviral Therapy(ART) and monitored closely by clinic visit and laboratory testing of blood sample collected during each visit.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 19, 2022|
|Estimated Primary Completion Date :||July 19, 2025|
|Estimated Study Completion Date :||July 19, 2025|
Study participants will be taken off antiretroviral therapy and blood samples will be collected during each clinic visit.
Other: Antiretroviral Therapy Interruption(ATI)
Study participant that were previously infused with autologous genetically modified cell product will be taken off ART and followed closely by monitoring HIV rebound.
- HIV kinetics [ Time Frame: 3 Years ]Observe for changes in the HIV viral load.
- CD T cell changes [ Time Frame: 3year ]Observe the changes in the CD4 T cells and CD8 T cells count following antiretroviral treatment interruption(ATI)
- Assess the durability of AGT103-T gene-modified cells during and after ATI [ Time Frame: 3 Year ]Measure the AGT103-T gene-modified cell during and after ATI
- CD T cells changes [ Time Frame: 3 Years ]Measure changes in frequency of Gag-specific CD4 and CD8 T cells following ATI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05540964
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Washington Health Institute|
|Washington, District of Columbia, United States, 20017|