The DART DELIVER-02 Study

This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART). The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help expose HIV in cells to the antibodies. The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are given. In this study, participants will be randomly assigned to one of three groups. All participants receive MGD014 and MGD020, given sequentially as infusions through an IV for 4 doses. Participants in one group (group A) receive only MGD014 and MGD020. Participants in another group (group B) will stop taking their ART therapy for up to 8 weeks (a temporary treatment interruption (TTI)) while receiving MGD014 and MGD020. Participants in the third group (group C) receive Vorinostat in addition to MGD014 and MGD020. Total time of participation is about 8 months and involves 13 or 18 visits, depending on group assignment.

NCT Number	NCT07217379
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, National Institute of Allergy and Infectious Diseases (NIAID), United States Department of Defense
Conditions	HIV (Human Immunodeficiency Virus)
Enrollment	24 participants
Start Date	2025-10-02
Primary Completion	2026-12 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2025-12-12