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The DART DELIVER-02 Study for HIV

This research study is looking at the safety and how well people with HIV (PWH) tolerate new experimental drugs called MGD014 and MGD020. These are antibodies designed to target HIV. The study also includes Vorinostat, an oral medication that helps expose hidden HIV in cells. You would receive MGD014 and MGD020 through an IV. Some participants will also take Vorinostat, and some will temporarily stop their regular HIV medication (antiretroviral therapy or ART). The study aims to see how safe these treatments are and how long MGD014 and MGD020 stay in your body. We're also looking at how these treatments affect inactive HIV in cells. The study is currently recruiting 24 participants between 18 and 65 years old who have documented HIV infection.

Study design
This is an open-label study, meaning you and the study team will know which treatment you are receiving. You will be randomly assigned to one of three groups. This study is a pilot, Phase 1 study.
What's involved
You would receive MGD014 and MGD020 infusions through an IV for 4 doses. Depending on your group, you might also take Vorinostat orally or temporarily stop your regular ART.
Compensation
Not stated in the trial record.
Follow-up
The study will measure adverse events up to Week 8, Week 10, or Week 14, depending on your assigned group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217379

The DART DELIVER-02 Study

Suspended
PHASE1Ages 18–65InterventionalTreatment
University of North Carolina, Chapel Hill
~24 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:MGD020MGD014VorinostatTemporary treatment interruption

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of Participants Experiencing At Least One Grade 3 or Greater Adverse Event that are Possibly or Definitely Related to Study Treatment
Measured over Day 0 through Week 8 (Arm A), Week 10 (Arm B), and Week 14 (Arm C)
+1 more outcome measured

Conditions

HIV (Human Immunodeficiency Virus)

Explore related trials

HIV InfectionCD4 Gene

Where it's being run

3 sites across 2 states
Kenya2
North Carolina1

Study leadership

  • Cynthia L. Gay, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

any licensed rapid HIV test
HIV antibody test
HIV Ag/Ab assay
licensed Western blot of HIV ½ antibody differentiation immunoassay
a second antibody test by a method other than the initial rapid HIV and/or HIV antibody assay
HIV-1 antigen, plasma HIV-1 RNA viral assay. 2. Ages ≥ 18 to ≤ 65 years old 3. Able and willing to give written informed consent. 4. Able and willing to stay in contact with site during the duration of the trial 5. Able and willing to provide adequate locator information. 6. Able and willing to comply with all study requirements through duration of the trial. 7. Continuous ART for a minimum of 24 months prior to screening, defined as not missing more than 9 consecutive days in the last 3 months prior to screening. 8. No change in any ART medication in the 30 days prior to screening. 9. Permitted ART regimens include:
Condoms (internal or external) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Tubal ligation
Hormone-based contraceptive 21. Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans. 22. Willingness to defer live vaccinations (e.g., varicella, measles, mumps, rubella (MMR), yellow fever, oral polio, Mpox) from 30 days prior to enrollment through week 16. 23. Willingness to defer routine vaccination, including influenza, from 14 days prior to enrollment through Week 16 of the study.

What this trial measures

  • Percent of Participants Experiencing At Least One Grade 3 or Greater Adverse Event that are Possibly or Definitely Related to Study TreatmentDay 0 through Week 8 (Arm A), Week 10 (Arm B), and Week 14 (Arm C)

    Safety data will include signs/symptoms, lab toxicities, and/or clinical events that are probably or definitely related to study treatment MGD014, MGD020, Temporary Treatment Interruption (TTI) and/or Vorinostat (VOR) through two weeks post completion of study treatment. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening.

  • Proportion of Participants who Received Full Course of Study TreatmentDay 0 through Week 6 (Arm A), Week 8 (Arm B), and Week 12 (Arm C)

    Receipt of the full course of study treatment is defined as receipt of all four MGD014 and MGD020 infusions. In addition for Arm B, the temporary treatment interruption (TTI) must have been longer than 10 days. In addition for Arm C, the participant must have received at least 16 Vorinostat (VOR) doses (Arm C).