Actively Recruiting
The DART DELIVER-02 Study
Led by University of North Carolina, Chapel Hill · Updated on 2025-12-12
24
Participants Needed
3
Research Sites
69 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The DART DELIVER-02 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV infection confirmed by licensed tests before study entry
- Age between 18 and 65 years
- Able and willing to provide written informed consent
- Able and willing to stay in contact with the study site during the trial
- Able and willing to provide adequate locator information
- Able and willing to follow all study requirements for the trial duration
- On continuous ART for at least 24 months prior to screening with minimal missed doses
- No changes in ART medication in the 30 days before screening
- Using permitted ART regimens with specific combinations of agents
- Have an alternative ART regimen available if assigned to the treatment interruption group
- Willing and able to continue ART or temporarily stop ART under supervision as assigned
- Plasma HIV-1 RNA less than 50 copies/mL at two points in the last 24 months
- No HIV RNA 200 copies/mL or higher in the 6 months before screening
- CD4 cell count of at least 400 cells/mm3 at screening
- Negative Hepatitis C antibody test (or negative HCV RNA if antibody positive) depending on site
- Negative Hepatitis B surface antigen test
- Women of child-bearing potential must have a negative pregnancy test at screening
- Willingness to use birth control and avoid conception during and 6 months after the study
- Agreement to avoid live and routine vaccinations during specified periods
- Willingness to avoid blood donation during the study
- Participants with type 2 diabetes must meet specific blood sugar control criteria
- Adequate organ function based on laboratory tests
You will not qualify if you...
- Pregnant or breastfeeding women
- Untreated syphilis infection
- Current or recent treatment for Hepatitis C
- Recent infusion of blood products or growth factors
- Starting ART within 90 days of acute HIV diagnosis
- Use of certain antiretroviral drugs that interfere with study drugs
- Use of long-acting antiretroviral regimens
- Recent use of immunomodulatory or certain other medications
- Planned use of immunomodulatory treatment during the study
- Recent or anticipated use of systemic corticosteroids beyond allowed doses
- Use of medications that increase risk of heart rhythm problems
- Recent use of histone deacetylase inhibitors like valproic acid
- Participation in other investigational treatments recently
- Serious illness requiring treatment or hospitalization recently
- Medical, psychiatric, or substance abuse conditions interfering with the study
- History of cancer within 3 years except certain skin cancers
- Immune deficiency other than HIV
- High blood pressure uncontrolled in the past 6 months
- Certain heart rhythm abnormalities
- History of pancreatitis or bleeding disorders requiring special care
- History of blood clots or angioedema
- Allergy or sensitivity to study drug components
- Unstable or severe asthma
- Active chronic skin problems not controlled by treatment
- Inability to communicate effectively with study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
2
Moi University Clinical Research Center
Eldoret, Kenya
Not Yet Recruiting
3
Kenya Medical Research Institute/Walter Reed Project
Kericho, Kenya
Not Yet Recruiting
Research Team
S
Susan Pedersen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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