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Study identifier: NCT07217379 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

The DART DELIVER-02 Study

Condition: HIV (Human Immunodeficiency Virus)  ·  Sponsor: University of North Carolina, Chapel Hill

PhasePhase 1
Planned participants24
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Susan Pedersen  ·  919-966-6713  ·  susan_pedersen@med.unc.edu

Always discuss trial participation with your own doctor first.

Locations (3)

University of North CarolinaChapel Hill, North Carolina, United StatesRecruiting
Moi University Clinical Research CenterEldoret, KenyaNot Yet Recruiting
Kenya Medical Research Institute/Walter Reed ProjectKericho, KenyaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07217379