NCT00672191

Phase II Study of AGS-004 as an Immunotherapeutic in Antiretroviral Therapy (ART)-Treated Subjects Infected With HIV

A Phase II Study Testing the Activity and Safety of AGS-004 as an Immunotherapeutic in Successfully ART-Treated Subjects Infected With HIV-1 in Combination With ART Followed by ART Interruption

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Argos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated, to determine if immunotherapy increases the body's immune response to HIV-1; and, to determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.

Detailed description

Although chronic ART raises cluster of differentiation CD 4+ T cell counts and improves immune function, the immune systems' ability to control HIV-1 replication is not improved. AGS-004 is an immunotherapeutic agent made from autologous DCs co electroporated with amplified in vitro transcribed (IVT) ribonucleic acid (RNA) encoding CD40L and with IVT RNA encoding three or four autologous HIV-1 antigens. The HIV-1 RNA is derived from the plasma sample taken immediately prior to the initiation of ART.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	AGS-004	HIV-1 Immune Therapy

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-08-01
• Completion: 2011-11-01
• First posted: 2008-05-06
• Last updated: 2013-01-29

Locations

12 sites across 2 countries: United States, Canada