The DART DELIVER-02 Study

Summary

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.

Conditions

• HIV (Human Immunodeficiency Virus)

Interventions

DRUG

MGD020

Administered intravenously at 300mg/kg over 60 minutes.

DRUG

MGD014

Administered intravenously at 300mg/kg over 60 minutes.

DRUG

Vorinostat

Administered orally at 400 mg every 72 hours.

OTHER

Temporary treatment interruption

Discontinuation of antiretroviral therapy (ART) through Week 8. If a participant meets protocol-defined ART restart criteria during the temporary treatment interruption (TTI), ART will be reinitiated immediately. Participants who do not meet restart criteria will remain off ART and continue weekly monitoring until Week 8, at which point ART will be resumed.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  collaborator OTHER

• US Military HIV Research Program

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• United States Department of Defense

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Cynthia L. Gay, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-02

Primary Completion

2026-12-31

Completion

2027-02-28

FDA Drug

Yes

Countries

• United States
• Kenya

Study Locations