A Phase 1 Study to Test Safety and Tolerability of Antibodies MGD014 and MGD020 With or Without Vorinostat or Treatment Pause in Adults With HIV on Antiretroviral Therapy

What this Trial Is About

Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, combined with antiretroviral therapy ART in people living with HIV. The study also looks at the effects of adding Vorinostat, an oral medication that helps expose hidden HIV in cells, or temporarily stopping ART to understand their impact on non-active HIV. This phase 1, pilot, open-label study aims to compare these treatment approaches and measure how long the antibodies stay in the body. Participants will be randomly assigned to one of three groups. All receive four doses of MGD014 and MGD020 by intravenous infusion over several weeks. One group continues ART with the antibodies, another stops ART temporarily while receiving the antibodies, and the third group receives the antibodies plus Vorinostat taken orally every 72 hours in two treatment cycles. The infusions and oral medication schedules vary by group, spanning about 8 months with 13 to 18 visits depending on the assigned arm. During the study, participants undergo regular clinical assessments including safety labs, viral load, and CD4 cell counts. Blood samples are collected for detailed virologic and immunologic testing. An independent safety monitor reviews safety data throughout the trial. The main outcomes measured are adverse events related to the treatments and completion of the full course. Pharmacokinetics of the antibodies and formation of anti-drug antibodies are also monitored over time.

The DART DELIVER-02 Study