The DELIVER 02/DART Phase 1 clinical study began in late 2025 at the University of North Carolina in the U.S. Two partner sites in Kenya, the KEMRI Kericho Clinical Research Center and the Moi University Clinical Research Center, are now preparing to begin study implementation as part of the DELIVER global HIV cure research agenda.
This study is evaluating the safety and tolerability of two antibody-based investigational products, MGD020 and MGD014 DART, in people living with HIV who are virally suppressed on ART. Three treatment groups will receive the DART molecules alone, in combination with an HIV latency reversing agent, or with a closely monitored temporary treatment interruption.
DART, or Dual-Affinity Re-Targeting proteins, are specialized, bispecific molecules developed by Duke University, the University of North Carolina at Chapel Hill and MacroGenics, Inc. to treat HIV by acting as a "shock-and-kill" strategy. They work by binding to HIV-infected cells and simultaneously engaging killer T cells, forcing them to destroy the infected cells. DARTs can help eliminate hidden HIV reservoirs, offering a potential cure strategy, as noted in studies.
https://clinicaltrials.gov/study/NCT07217379
