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RECRUITING Phase 1

The DART DELIVER-02 Study

NCT07217379 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07217379

The ClinicalTrials.gov registry entry for NCT07217379 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07217379 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Other, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07217379?

The interventions under investigation include: Vorinostat (DRUG), MGD020 (DRUG), MGD014 (DRUG), Temporary treatment interruption (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07217379?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial