At a glance
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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
In Brief
A Phase 1 clinical trial evaluating AGS-004 for HIV. Completed, enrolled 6 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
All participants in both arms will receive the same treatment and doses of AGS-004 in Step 2 at weeks 0, 4, 8, and 12.