NCT07217379

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a phase 1, pilot, open-label study of MGD014 in combination with MGD020 in PWH on ART. The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of the study drugs alone, and in combination with an latency reversal agent (LRA) or a TTI. Participants will be enrolled, undergo an initial evaluation and baseline sample collections, and then be randomized to 1 of 3 arms as follows: Arm A: Continue baseline ART and receive biweekly MGD014/ MGD020 infusions at Day 0, weeks 2, 4 and 6. Arm B: Initiate biweekly MGD014/ MGD020 infusions at Day 0 and undergo a TTI from Day 4 to week 8. Arm C: Continue baseline ART, receive MGD014/ MGD020 infusions at Day 0, week 2, 8, and 10 in combination with VOR 400mg every 72 hours from Day 0 to week 4 and week 8-12 The study design will allow comparison of the impact of MGD014/MGD020 administration with continued ART alone, to MGD014/MGD020 administration with two different methods of latency reversal, 1) VOR, a latency reversal agent, and 2) TTI. All participants will receive a total of 4 doses of MGD014/MGD020 at 300 mcg/kg administered as intravenous infusion. In Arms A and B, MGD014/MGD020 will be infused every 2-3 weeks. In Arm C, participants will receive two doses of MGD014/MGD020 at weeks 0 and 2, then again at weeks 8 and 10.In Arm C, participants will receive VOR 400 mg orally every 72 hours for 10 doses from Day 0 to week 4, and a second cycle of VOR 400 mg orally every 72 hours for 10 doses from week 8 to 12. Study participants will have regular clinical assessments, including safety labs, viral load measurements, and CD4+ cell counts. Specimens will be stored for virologic and immunologic studies, including but not limited to comprehensive assessments of viral integrants, cell-associated HIV RNA, PK of MGD014/MGD020, and biomarkers of VOR exposure. An independent safety monitor will provide study oversight and evaluate cumulative safety and other clinical data at regular intervals.

Conditions

• HIV (Human Immunodeficiency Virus)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2025-10-16
• Last updated: 2025-12-12

Locations

3 sites across 2 countries: United States, Kenya

Regulatory

• FDA-regulated drug study