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A Phase I Study to Evaluate the Immunologic Response and Virologic Impact of AGS-004

HIV Clinical Trial

Official title:
IGHID 1309 -A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Impact of AGS-004 in HIV-Infected Individuals Suppressed on Antiretroviral Therapy Initiated During Acute and Chronic HIV Infection

Clinical Trial Summary

The purpose of this study is to:

- find out the intensity and duration of the immune response after multiple injections of the investigational study product AGS-004 made from one's own dendritic cells and one's own strain of HIV;

- understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting CD4+ cells prior to and following administration of AGS- 004.

- find out if low levels of HIV virus that are not detectable by standard HIV RNA assays will decrease following the administration of AGS-004.

- find out if it is safe to give individuals with HIV multiple injections of AGS-004 made from the person's own dendritic cells and their own strain of HIV.

- find out if administration of AGS-004 decreases the amount of latent HIV infection in resting CD4 cells

Clinical Trial Description

This is a phase I, single-site, pilot study of the kinetics of the immunological response and virological impact of AGS-004 administered in participants with durable viral suppression on ART initiated during acute (AHI) and chronic HIV infection (CHI). Patients will be screened for eligibility in Step 1. Those meeting study eligibility and with successful production of Argos (AGS)-004 product will then enter Step 2 with administration of AGS-004. All participants will continue ART throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02042248
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 1
Start date March 2014
Completion date May 2016
View Details
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