MGD020 + MGD014 for HIV
(DELIVER-02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and tolerance of two experimental antibody treatments, MGD014 and MGD020, for people living with HIV. Vorinostat, a drug that helps reveal hidden HIV in cells, is also used to assess how the antibodies perform in different scenarios. Participants will be divided into three groups to test these treatments in various combinations, with one group temporarily pausing their usual HIV medications. This trial may suit individuals who have maintained stable antiretroviral therapy (ART) for at least two years and have not recently shown high levels of HIV in their blood. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive these new treatments.
Do I have to stop taking my current medications for the trial?
If you are in group B, you will need to stop taking your antiretroviral therapy (ART) for up to 8 weeks during the trial. If you are in groups A or C, you will continue your current ART.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is investigating the safety of using MGD014 and MGD020 together in people with HIV who are also on antiretroviral therapy (ART). Early results suggest this combination might be safe, but it remains under close study. Researchers monitor the body's reactions to these drugs and any potential side effects.
For the combination of MGD014, MGD020, and Vorinostat, research is in its initial stages. As this is a Phase 1 trial, the primary goal is to assess the treatment's safety and tolerability. Scientists are examining any side effects and their severity.
Vorinostat has approval for some other conditions, providing some knowledge about its safety in humans. However, its use with MGD014 and MGD020 is new, requiring further information to confirm safety.
In a Phase 1 trial, safety is the top priority, and researchers carefully monitor all participants for any adverse effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments MGD014 and MGD020 for HIV because they offer a novel approach compared to current options, like antiretroviral therapy. MGD014 and MGD020 work by enhancing the immune response against HIV, potentially offering a new mechanism to control the virus. Unlike standard treatments that require daily medication, these investigational drugs are administered via infusions, which may lead to longer-lasting effects. Additionally, the combination of MGD014 and MGD020 with temporary treatment interruption or Vorinostat could provide insights into optimizing HIV management, making these treatments a promising frontier in HIV therapy.
What evidence suggests that this trial's treatments could be effective for HIV?
Research has shown that MGD014 and MGD020 are promising treatments for HIV. Early lab studies indicate that MGD014 helps certain white blood cells, called T cells, effectively kill cells infected with HIV. MGD020 targets specific parts of the HIV virus to support the immune system. In this trial, participants will receive infusions of MGD014 and MGD020. Some participants will receive these infusions alone, while others will receive them with a temporary treatment interruption or with Vorinostat. When used together, MGD014 and MGD020 have shown greater effectiveness in reducing dormant HIV in cells. In studies with humanized mice, this combination significantly improved the ability to target HIV. These findings suggest that these treatments could effectively manage HIV.12467
Who Is on the Research Team?
Cynthia L. Gay, MD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for people with HIV who are on antiretroviral therapy. Participants must be willing to potentially pause their current HIV treatment and receive experimental antibodies, MGD014 and MGD020, through IV infusions. Some will also take Vorinostat orally.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MGD014 and MGD020 infusions, with some groups also receiving Vorinostat or undergoing a temporary treatment interruption
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and pharmacokinetics
Long-term Follow-up
Participants are monitored for long-term safety and immunogenicity, including anti-drug antibody formation
What Are the Treatments Tested in This Trial?
Interventions
- MGD014
- MGD020
- Vorinostat
Trial Overview
The DART DELIVER-02 Study tests the safety of two HIV-specific antibodies (MGD014 and MGD020) and an oral medication called Vorinostat in individuals with HIV/AIDS. The study explores how these treatments affect dormant HIV in cells and measures how long the drugs stay active in the body.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
MGD014 and MGD020 infusions at Day 0, Week 2, Week 4 and Week 6.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
US Military HIV Research Program
Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
United States Department of Defense
Collaborator
Citations
A Study of MGD020 Alone or Combined With MGD014 in ...
A phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in persons with HIV-1 (PWH) on ...
Bispecific antibody-derived molecules to target persistent ...
This study will also evaluate the safety and PK of the MGD014 + MGD020 combination. The results from these studies will support future clinical studies in which ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-mgd020-alone-or-combined-with-mgd014-in-persons-with-hiv-1-on-antiretroviral-therapyA Study of MGD020 Alone or Combined With MGD014 in ...
Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination ...
MGD020 + MGD014 for HIV · Info for Participants
Early lab studies indicate that MGD014 can effectively assist T cells in killing HIV-infected cells. Although these results are promising, they are based on lab ...
Trial | NCT05261191
MGD020 is a bispecific DART® molecule that binds CD3 and gp41 subunit of HIV-1 envelope. MGD014 is a bispecific DART® molecule that binds CD3 and gp120 subunit ...
The DART DELIVER-02 Study | Clinical Research Trial ...
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 ...
NCT05261191
The combination of MGD020 and MGD014 has the potential to enhance the recognition of rare actively infected cells in individuals that express env glycoproteins ...
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