What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapies (ART), often include drugs like bictegravir, emtricitabine, tenofovir alafenamide, dolutegravir, abacavir, and lamivudine. These treatments are generally well-tolerated but can have side effects. Common side effects include nausea, diarrhea, headache, and fatigue. Some patients may experience more severe side effects such as liver toxicity, renal impairment, and hypersensitivity reactions. Long-term use of ART can also lead to metabolic changes, including lipid abnormalities and insulin resistance. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies for the treatment of HIV, including protease inhibitors, reverse transcriptase inhibitors, and integrase strand transfer inhibitors. While specific bispecific DART® molecules like MGD020 and MGD014 are still under investigation, other advanced therapies such as monoclonal antibodies and combination antiretroviral therapies have been approved. These treatments aim to reduce viral load and improve immune function in individuals with HIV.

What other types of research exist?

Promising novel alternatives to MGD020 and MGD014 for HIV treatment include MK-8591 (4'-ethynyl-2-fluoro-2'-deoxyadenosine [EFdA]), a novel reverse transcriptase-translocation inhibitor, and long-acting injectable antiretrovirals such as cabotegravir and rilpivirine. These alternatives offer innovative mechanisms of action and have shown efficacy in clinical trials.

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Bispecific DART molecule

MGD020 + MGD014 for HIV

Phase 1

Waitlist Available

Research Sponsored by MacroGenics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On continuous antiretroviral therapy (ART) for at least 24 months prior to screening and must continue ART throughout the study

Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent

Must not have

Active viral, bacterial, or systemic fungal infection requiring intravenous antibiotic, antiviral, or antifungal treatment within 7 days prior to the initiation of study drug

History of virologic failure on an ART regimen containing FDA-approved HIV-1 entry inhibitors (maraviroc, enfuvirtide, and/or ibalizumab). Virologic failure is defined as a confirmed plasma HIV-1 RNA ≥ 150 copies/mL following assessment of drug adherence, repeat HIV-1 RNA testing with continued treatment, and/or resistance testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two new drugs, MGD020 and MGD014, in people with HIV who are already on treatment. These drugs help the immune system find and kill HIV-infected cells by acting as a bridge between immune cells and the virus.

Who is the study for?

This trial is for adults aged 18-70 with well-controlled HIV on antiretroviral therapy (ART) for at least 24 months, having a viral load under 50 copies/mL. They must have stable health, no recent serious infections or COVID-19, and not be in other studies. Participants should agree to contraception use during the study and for four months after.

What is being tested?

The trial tests MGD020 alone or combined with MGD014 in people with HIV. It's an early-phase study assessing safety, tolerability, how the body processes these drugs (pharmacokinetics), immune response (immunogenicity), and drug effects (pharmacodynamics). The treatment involves different doses of MGD020 followed by combination doses with MGD014.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to immune-based therapies such as infusion-related symptoms, changes in blood counts or organ function due to redirected T cell activity against infected cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on HIV medication for at least 2 years and will continue it during the study.

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I am between 18 and 70 years old and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed IV treatment for an infection in the last 7 days.

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I have HIV and my previous treatment with specific HIV medications was not successful.

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I currently have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1, 2, 3, 8, 15, 29, and 43 for parts 1a and 1b. study day 1, 2, 3, 8, 15, 29, 43, 50, 64, and 78 for part 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation in participants receiving MGD020 and MGD014 in Part 2.

Secondary study objectives

AUC of MGD014

Anti-drug antibody formation to MGD014

Anti-drug antibody formation to MGD020

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 2: MGD020 and MGD014Experimental Treatment2 Interventions

Multiple doses of MGD020 and MGD014

Group II: Part 1B: MTD/MAD MGD020 and MGD014Experimental Treatment2 Interventions

Single dose MGD020 and MGD014

Group III: Part 1B: MTD/MAD -1 MGD020 and MGD014Experimental Treatment2 Interventions

Single dose MGD020 and MGD014

Group IV: Part 1A: Dose level 6Experimental Treatment1 Intervention

Single dose MGD020

Group V: Part 1A: Dose level 5Experimental Treatment1 Intervention

Single dose MGD020

Group VI: Part 1A: Dose level 4Experimental Treatment1 Intervention

Single dose MGD020

Group VII: Part 1A: Dose level 3Experimental Treatment1 Intervention

Single dose MGD020

Group VIII: Part 1A: Dose level 2Experimental Treatment1 Intervention

Single dose MGD020

Group IX: Part 1A: Dose level 1Experimental Treatment1 Intervention

Single dose MGD020

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MGD020

2022

Completed Phase 1

~30

MGD014

2022

Completed Phase 1

~50

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV include antiretroviral therapies (ART) that target various stages of the HIV life cycle to prevent the virus from replicating. MGD020 and MGD014 are bispecific DART® molecules that redirect CD3+ T lymphocytes to kill HIV-1-infected CD4+ T cells by targeting the gp41 and gp120 subunits of the HIV-1 envelope, respectively. This mechanism is crucial as it directly enhances the immune system's ability to eliminate infected cells, potentially reducing the viral reservoir and improving long-term outcomes for patients. Other ARTs, such as integrase inhibitors (e.g., bictegravir) and reverse transcriptase inhibitors (e.g., emtricitabine and tenofovir alafenamide), work by inhibiting viral enzymes necessary for HIV replication. These treatments are essential for maintaining viral suppression, preventing disease progression, and reducing the risk of transmission.

Interaction of C-terminal sequences of human immunodeficiency virus reverse transcriptase with template primer.Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial.Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial.