Reference:
Jacobson, J. M., Routy, J.-P., Welles, S., DeBenedette, M., Tcherepanova, I., Angel, J. B., Asmuth, D. M., Stein, D. K., Baril, J.-G., McKellar, M., Margolis, D. M., Trottier, B., Wood, K., & Nicolette, C. (2016). Dendritic cell immunotherapy for HIV-1 infection using autologous HIV-1 RNA: A randomized, double-blind, placebo-controlled clinical trial. Journal of Acquired Immune Deficiency Syndromes, 72(1), 31–38. https://doi.org/10.1097/QAI.0000000000000926
Summary:
This phase IIB clinical trial evaluated AGS-004, a dendritic cell immunotherapy using autologous HIV-1 RNA, in HIV-1-infected patients on antiretroviral therapy. Fifty-four participants were randomised to receive AGS-004 or placebo. The primary endpoint, plasma HIV-1 RNA levels at the end of a 12-week analytical treatment interruption (ATI), showed no significant difference between the two groups. However, AGS-004 recipients exhibited a higher frequency of HIV-specific CD8 T-cell responses. Adverse events were mild and comparable between groups. These findings suggest that while AGS-004 can induce immune responses, it did not translate to improved HIV control during ATI, highlighting ongoing challenges in HIV immunotherapy.