Actively Recruiting
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
Led by University of North Carolina, Chapel Hill · Updated on 2025-12-12
24
Participants Needed
3
Research Sites
8 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
Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, combined with antiretroviral therapy (ART) in people living with HIV. The study also looks at the effects of adding Vorinostat, an oral medication that helps expose hidden HIV in cells, or temporarily stopping ART to understand their impact on non-active HIV. This phase 1, pilot, open-label study aims to compare these treatment approaches and measure how long the antibodies stay in the body. Participants will be randomly assigned to one of three groups. All receive four doses of MGD014 and MGD020 by intravenous infusion over several weeks. One group continues ART with the antibodies, another stops ART temporarily while receiving the antibodies, and the third group receives the antibodies plus Vorinostat taken orally every 72 hours in two treatment cycles. The infusions and oral medication schedules vary by group, spanning about 8 months with 13 to 18 visits depending on the assigned arm. During the study, participants undergo regular clinical assessments including safety labs, viral load, and CD4 cell counts. Blood samples are collected for detailed virologic and immunologic testing. An independent safety monitor reviews safety data throughout the trial. The main outcomes measured are adverse events related to the treatments and completion of the full course. Pharmacokinetics of the antibodies and formation of anti-drug antibodies are also monitored over time.
CONDITIONS
Brief Title
The DART DELIVER-02 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV infection confirmed by licensed tests before study entry
- Age between 18 and 65 years
- Able and willing to provide written informed consent
- Willing to stay in contact with the study site during the trial
- Able to provide adequate locator information
- Willing to comply with all study requirements throughout the trial
- On continuous antiretroviral therapy for at least 24 months without missing more than 9 consecutive days in the last 3 months
- No changes in ART medications in the 30 days prior to screening
- Using permitted ART regimens including specific combinations of agents
- Have an alternative effective ART option if assigned to temporary treatment interruption
- Willing to continue or temporarily stop ART under supervision as assigned
- Plasma HIV-1 RNA below 50 copies/mL at two time points in past 24 months
- No HIV RNA above 200 copies/mL in the 6 months prior to screening
- CD4 cell count of at least 400 cells/mm3 at screening
- Negative hepatitis C antibody or RNA as required
- Negative hepatitis B surface antigen at screening
- Women of child-bearing potential must have a negative pregnancy test at screening
- Willing to use effective contraception and avoid conception during and 6 months after study
- Willing to abstain from risky sexual activity or use prevention methods if partner HIV status is negative or unknown during treatment interruption
- Agree not to participate in other investigational drug studies during this trial
- Willing to defer live and routine vaccinations during specified periods
- Willing to refrain from blood donation during the study
- Participants with type 2 diabetes must meet specific glucose control criteria
- Adequate organ function based on study laboratory values
You will not qualify if you...
- Pregnant or breastfeeding women
- Untreated active syphilis infection
- Current or recent treatment for hepatitis C
- Recent infusion of blood products or growth factors
- Started 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 anticoagulant medications
- Intent to use immunomodulatory treatments during the study
- Recent or anticipated use of systemic corticosteroids beyond specified limits
- Use of medications that increase risk of serious heart rhythm problems
- Recent use of histone deacetylase inhibitor-like compounds
- Participation in other investigational treatments recently
- Serious illnesses requiring systemic treatment or hospitalization unless stable
- Medical, psychiatric, or substance abuse conditions affecting study adherence
- Recent history of malignancy except certain skin cancers
- Immune deficiency other than HIV
- Uncontrolled high blood pressure
- Significant heart rhythm abnormalities
- History of pancreatitis or bleeding disorders requiring special care
- History of blood clots
- History of certain angioedema types
- Known allergies to study drug components
- Unstable asthma or asthma requiring specific treatments
- Active chronic skin conditions not controlled by treatment
- Inability to communicate effectively with study personnel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks depending on arm
Participants receive 4 doses of MGD014 and MGD020 intravenously at 300 mcg/kg on a schedule depending on their assigned arm. Arm A receives infusions at Day 0, Week 2, Week 4, and Week 6 with continued ART. Arm B receives infusions at Day 0, Week 2, Week 4, and Week 6 with a temporary treatment interruption of ART from Day 4 to Week 8. Arm C receives infusions at Day 0, Week 2, Week 8, and Week 10 combined with oral Vorinostat every 72 hours from Day 0 to Week 4 and again from Week 8 to Week 12.
4 infusion visits plus additional visits for oral medication and monitoring depending on arm assignment
Duration - Up to 26 weeks after treatment start
Participants undergo regular clinical assessments including safety labs, viral load measurements, and CD4+ cell counts. Specimens are collected for pharmacokinetics and immunologic studies through Week 26.
Regular visits for clinical and laboratory assessments
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
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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