NCT07217379 (DELIVER-02) is a Phase 1 clinical trial of MGD020 in HIV (Human Immunodeficiency Virus), sponsored by University of North Carolina, Chapel Hill.

Who is sponsoring NCT07217379?

NCT07217379 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT07217379?

Interventions in NCT07217379: MGD020, MGD014, Vorinostat, Temporary treatment interruption.

What condition does NCT07217379 study?

NCT07217379 studies HIV (Human Immunodeficiency Virus).

Is NCT07217379 still recruiting?

NCT07217379 is currently recruiting now. Last updated 8 December 2025.

Last reviewed 2025-12-08 · How we verify

NCT07217379: DELIVER-02

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IGHID 12430 - Deliver-02 - A Phase 1, Open Label, Randomized Study To Evaluate The Safety And Tolerability Of MGD014 And MGD020 With A Latency Reversal Agent Versus Temporary Treatment Interruption In Persons With HIV-1 On Antiretroviral Therapy

Recruiting now Phase 1 Last updated 8 December 2025

What this trial tests

Phase 1 trial testing MGD020 in HIV (Human Immunodeficiency Virus) in 24 participants. Currently enrolling.

Timeline

2 October 2025

Primary endpoint
1 December 2026

1 February 2027

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	2 October 2025
Primary completion	1 December 2026
Estimated completion	1 February 2027
Sites	3 locations across United States, Kenya

Drugs / interventions tested

MGD020 — full drug profile →
MGD014 — full drug profile →
Vorinostat (VORINOSTAT) — full drug profile →
Temporary treatment interruption

Conditions studied

HIV (Human Immunodeficiency Virus) — all drugs for HIV (Human Immunodeficiency Virus) →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 65, any sex, with HIV (Human Immunodeficiency Virus). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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)
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,
Proportion of Participants who Received Full Course of Study Treatment
Time frame: Day 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).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of MGD020

Trials testing the same drug.

NCT05261191 — A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy · Phase 1 · completed

Other recruiting trials for HIV (Human Immunodeficiency Virus)

Currently open trials in the same condition.

NCT07495059 — Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care · NA · recruiting
NCT07115901 — Guaranteed Income to Boost HIV Care Continuity and Suppression Post-Jail Release · NA · recruiting
NCT07336797 — Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy · Phase 2 · recruiting
NCT07062614 — Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a · recruiting
NCT07150871 — Impact of Covid-19 on Syphilis · active not recruiting

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07217379 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 8 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07217379.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing