RecruitingPhase 1NCT07217379

The DART DELIVER-02 Study

IGHID 12430 - Deliver-02 - A Phase 1, Open Label, Randomized Study To Evaluate The Safety And Tolerability Of MGD014 And MGD020 With A Latency Reversal Agent Versus Temporary Treatment Interruption In Persons With HIV-1 On Antiretroviral Therapy

Sponsor

University of North Carolina, Chapel Hill

Enrollment

24 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

HIV (Human Immunodeficiency Virus)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (called DART DELIVER-02) is looking at whether long-acting injectable HIV medications can simplify treatment for people living with HIV who are already well-controlled on daily oral antiretroviral therapy (ART). The goal is to explore a less burdensome way to maintain HIV suppression. **You may be eligible if...** - You are between 18 and 65 years old and have confirmed HIV - You have been on continuous HIV medication (ART) for at least 2 years - Your HIV is suppressed (undetectable viral load) - Your current HIV medications include an integrase inhibitor or NNRTI - You have not changed your HIV medications in the last 30 days **You may NOT be eligible if...** - Your HIV is not well-controlled or you have missed more than 9 consecutive days of medication in the past 3 months - You are not on an eligible ART regimen - You are unable or unwilling to complete all study visits and requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMGD020

Administered intravenously at 300mg/kg over 60 minutes.

DRUGMGD014

Administered intravenously at 300mg/kg over 60 minutes.

DRUGVorinostat

Administered orally at 400 mg every 72 hours.

OTHERTemporary 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.