The DART DELIVER-02 Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07217379
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV (Human Immunodeficiency Virus)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MGD020 — DRUG
    Administered intravenously at 300mg/kg over 60 minutes.
  • MGD014 — DRUG
    Administered intravenously at 300mg/kg over 60 minutes.
  • Vorinostat — DRUG
    Administered orally at 400 mg every 72 hours.
  • Temporary treatment interruption — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - MGD014/MGD020 Infusions
    MGD014 and MGD020 infusions at Day 0, Week 2, Week 4 and Week 6.
  • Experimental: Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI)
    MGD014 and MGD020 infusions at Day 0, Week 2, Week 4, and Week 6 in combination with a TTI from Day 4 to Week 8.
  • Experimental: Arm C - MGD014/MGD020 Infusions with Vorinostat
    MGD014 and MGD020 infusions at Day 0, Week 2, Week 8, and Week 10 in combination with VOR from Day 0 to Week 4 and Week 8 to Week 12.

Primary Outcome Measure

Percent of Participants Experiencing At Least One Grade 3 or Greater Adverse Event that are Possibly or Definitely Related to Study Treatment [ Time Frame: Day 0 through Week 8 (Arm A), Week 10 (Arm B), and Week 14 (Arm C) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27514
Susan Pedersen
919-966-6713
Cindy Gay, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina· Chapel Hill, NC

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