The DART DELIVER-02 Study

NCT07217379 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 24-2690HT94252430004
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 3

Brief 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

HIV (Human Immunodeficiency Virus)

Keywords

HIV; latency reversal agent

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Experiencing At Least One Grade 3 or Greater Adverse Event that are Possibly or Definitely Related to Study Treatment

  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.

  Day 0 through Week 8 (Arm A), Week 10 (Arm B), and Week 14 (Arm C)

• Proportion of Participants who Received Full Course of Study Treatment

  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).

  Day 0 through Week 6 (Arm A), Week 8 (Arm B), and Week 12 (Arm C)

Secondary Outcomes (7)

• Serum PK Concentration of MGD020

  Day 0 through Week 26

• Serum PK Concentration of MGD014

  Day 0 through Week 26

• Incidence of Anti-drug Antibody (ADA) Formation to MGD020

  Day 0 through Week 24

• Incidence of Anti-drug Antibody (ADA) Formation to MGD014

  Day 0 through Week 24

• Number of Treatment Emergent Adverse Events (TEAEs)

  Day 0 through Week 26

Study Arms (3)

Arm A - MGD014/MGD020 Infusions

EXPERIMENTAL

MGD014 and MGD020 infusions at Day 0, Week 2, Week 4 and Week 6.

Drug: MGD020; Drug: MGD014

Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI)

EXPERIMENTAL

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.

Drug: MGD020; Drug: MGD014; Other: Temporary treatment interruption

Arm C - MGD014/MGD020 Infusions with Vorinostat

EXPERIMENTAL

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.

Drug: MGD020; Drug: MGD014; Drug: Vorinostat

Interventions

MGD020 DRUG

Administered intravenously at 300mg/kg over 60 minutes.

Arm A - MGD014/MGD020 Infusions; Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI); Arm C - MGD014/MGD020 Infusions with Vorinostat

MGD014 DRUG

Administered intravenously at 300mg/kg over 60 minutes.

Arm A - MGD014/MGD020 Infusions; Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI); Arm C - MGD014/MGD020 Infusions with Vorinostat

Vorinostat DRUG

Administered orally at 400 mg every 72 hours.

Arm C - MGD014/MGD020 Infusions with Vorinostat

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.

Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection initially documented by at least one of the following at any time prior to study entry:
• any licensed rapid HIV test
• HIV antibody test
• HIV Ag/Ab assay
• …and documented confirmation by at least one of the following at any time prior to study entry:
• 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.
• Ages ≥ 18 to ≤ 65 years old
• Able and willing to give written informed consent.
• Able and willing to stay in contact with site during the duration of the trial
• Able and willing to provide adequate locator information.
• Able and willing to comply with all study requirements through duration of the trial.
• 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.
• No change in any ART medication in the 30 days prior to screening.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Untreated syphilis infection defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment.
• Current treatment for HCV or HCV treatment within 6 months prior to enrollment.
• Received any infusion blood product or hematopoetic growth factors within 3 months prior to enrollment.
• Started ART within 90 days of diagnosis with acute HIV-1 infection.
• Use of antiretrovirals that might interfere with MGD014 or MGD020: maraviroc (Selzentry), enfuvirtide (T-20), fostemsavir (Rubokia), Ibalizumab (Trogarzo).
• Use of long-acting antiretroviral regimens given potential TTI.
• Use of any of the following agents within 90 days prior to enrollment: immunomodulatory, cytokine, or growth stimulating factors such as systemic cytotoxic chemotherapy or immune globulin, interferons, coumadin, warfarin, or other Coumadin derivative anticoagulants.
• Intent to use immunomodulatory treatment during the study.
• Use of systemic corticosteroids within 30 days prior to enrollment, or anticipated need for periodic use of systemic corticosteroids during the study.
• Note: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone ≤10 mg/day, are not excluded.
• Participants receiving inhaled, intranasal, topical, intermittent intra-articular corticosteroids, or topical imiquimod are not excluded.
• Concomitant use of oral/systemic /intra-articular/inhaled/intranasal corticosteroids is prohibited for participants receiving ritonavir or cobicistat.
• Use of the following medications that carry risk of torsade des pointes: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
• Receipt of compounds with histone deacetylase (HDAC) inhibitor-like activity, such as valproic acid within the last 30 days. Potential participants may enroll after a 30-day washout period.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• US Military HIV Research Program: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• United States Department of Defense: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (3)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Moi University Clinical Research Center

Eldoret, Kenya

NOT YET RECRUITING

Kenya Medical Research Institute/Walter Reed Project

Kericho, Kenya

NOT YET RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Study Officials

• Cynthia L. Gay, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Pedersen

CONTACT

919-966-6713; susan_pedersen@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 16, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months after publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1); KE (2)