Skip to main content

Volume 6 Supplement 3

AIDS Vaccine 2009

OA04-05. Safety and viral load changes in HIV-1 infected subjects treated with autologous dendritic immune therapy following ART discontinuation (CTN#239)

Background

We demonstrated in a phase 1 trial that an immunotherapy (AGS-004) consisting of a monocyte-derived dendritic cells (DC) and RNA encoding autologous HIV antigens (Gag, Nef, Rev, Vpr) derived from the patient's own pre-ART plasma induced immunogenicity in most patients. Based on these results a multicenter phase 2 trial was implemented to assess the safety and proportion of patients demonstrating viral load (VL) < 1000, < 5000 and < 10,000 copies/ml during the 12 week ART structured treatment interruption (STI).

Methods

Subjects on their initial ART regimen with VL < 50 copies/ml, CD4 > 450 cells/μl, CD4 nadir > 200 cells/μl and a pre-ART VL > 10,000 to 500,000 copies/ml were eligible. The treatment consists of 4 intradermal AGS-004 doses administered monthly in combination with ART followed by two more doses during the 12 week STI. Subjects who participated in the phase 1 study were included and received a second cycle of AGS-004. Subjects may continue AGS-004 booster administration if VL remains < 10,000 copies/ml.

Results

33 subjects were enrolled from 11 Canadian sites, and AGS-004 successfully manufactured and administered to 21 subjects. 9 subjects have successfully completed 12 weeks of STI. The immunotherapy related AEs were Grade 1 or 2 flu-like, GI symptoms, fatigue, and injection site reactions. During the STI, no reports of autoimmunity or AIDS defining events were observed. After an initial viral rebound, 4 out of 9 subjects had > 2 instances of VL measures < 1000 copies/mL when assessed every 2 weeks during the STI. At week 12 of STI 5 subjects had viral loads < 10,000 copies/ml with CD4 > 350 cells/μl including 4 subjects with viral loads < 5000 copies/ml.

Conclusion

Results from this phase 2 autologous immunotherapy trial demonstrated that this therapy is safe and induced partial control of VL when compared to pre-ART VL during the 12-week STI.

Author information

Affiliations

Authors

Corresponding author

Correspondence to J Routy.

Rights and permissions

Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Routy, J., Boulassel, M., Mona, L. et al. OA04-05. Safety and viral load changes in HIV-1 infected subjects treated with autologous dendritic immune therapy following ART discontinuation (CTN#239). Retrovirology 6, O29 (2009). https://doi.org/10.1186/1742-4690-6-S3-O29

Download citation

Keywords

  • Viral Load
  • Injection Site Reaction
  • Viral Rebound
  • Viral Load Measure
  • Immunotherapy Trial