MGD020 + MGD014 for HIV

(DELIVER-02 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.

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.

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.

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.

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