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NCT07217379 · ClinicalTrials.gov registry record · Phase 1

The DART DELIVER-02 Study

A Phase 1 study of HIV (Human Immunodeficiency Virus), sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
3
Study locations

NCT07217379: Recruiting Phase 1 study of HIV (Human Immunodeficiency Virus), sponsored by University of North Carolina, Chapel Hill.

NCT07217379 is a Phase 1 study of HIV (Human Immunodeficiency Virus) that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 80-participant average among 4 other HIV (Human Immunodeficiency Virus) trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07217379, a Phase 1 study of HIV (Human Immunodeficiency Virus), is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
3
Study locations

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 Studied

HIV (Human Immunodeficiency Virus)

Interventions

  • DRUG Vorinostat
  • DRUG MGD020
  • DRUG MGD014
  • OTHER Temporary treatment interruption

Study Locations (3)

Other

  • Moi University Clinical Research Center - Eldoret
  • Kenya Medical Research Institute/Walter Reed Project - Kericho

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-10-02
Est. Completion 2027-02
Phase Phase 1
University of North Carolina, Chapel Hill

1,109 total trials

What NCT07217379 shows while recruiting

NCT07217379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 80-participant average among 4 other HIV (Human Immunodeficiency Virus) trials with a reported enrollment target (70% lower).

The record links to 1 condition, with HIV (Human Immunodeficiency Virus) appearing as the primary indexed condition, and to 4 interventions - of which Vorinostat is the first listed.

NCT07217379 reports a single indexed study location in Other, North Carolina.

Frequently Asked Questions

What is clinical trial NCT07217379 about?

NCT07217379 is a clinical study titled "The DART DELIVER-02 Study". 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 med...

What is the current status of trial NCT07217379?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-10-02. Estimated completion is 2027-02.

What conditions does trial NCT07217379 study?

This clinical trial studies the following conditions: HIV (Human Immunodeficiency Virus).

What interventions are being tested in trial NCT07217379?

The interventions under investigation include: Vorinostat (DRUG), MGD020 (DRUG), MGD014 (DRUG), Temporary treatment interruption (OTHER).

Who is sponsoring clinical trial NCT07217379?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07217379 being conducted?

This trial has 3 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT07217379

Source: ClinicalTrials.gov NCT07217379, the US trial registry maintained by the National Library of Medicine. NCT07217379 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.