The National Institutes of Health’s (NIH) Division of AIDS and Infectious Disease Services (DAIDS) has pledged $6.6 million to support the first human clinical trial into a cure strategy known as “kick and kill.” This Phase IIa research will explore a one-two punch approach to attacking the viral reservoir. First researchers will attempt to make latently infected cells more visible to the immune system by “kicking” them out of their dormant state with a latency-reversing agent (in this case, what’s known as an HDAC inhibitor). They will also use an individual’s own virus to craft a virus-fighting immunotherapy, which the Durham, North Carolina, biotech company Argos Therapeutics calls AGS-004.

The desired result is that the body will better respond to the newly replicating HIV-infected cells and will proceed to eradicate the virus—which is where the “kill” part comes in.

“Previous study results suggest AGS-004 can induce anti-viral memory T-cell responses that are associated with lower persistent viral reservoirs when administered in combination with standard antiretroviral therapy,” said Charles Nicolette, PhD, Argos’ chief scientific officer and vice president of research and development. “The continued support of DAIDS allows us to move forward with stage two of our adult eradication trial, which has already been cleared for initiation by the FDA. We believe that this is the first human clinical trial to test the highly promising ‘kick and kill’ approach to treatment.”
“With this NIH funding, we can now study whether combining AGS-004 treatment with a latent reservoir mobilizer can lead to the elimination of HIV-infected cells,” said David Margolis, MD, of the University of North Carolina, principal investigator of the study, in the same release. “In stage two of this study, patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004.”

To read the press release, click here.