MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
Condition: HIV-1-infection
MeSH terms: Infections
Intervention: MGD014
Intervention description: HIV-1 x CD3 bispecific DART molecule
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label dose-escalation study
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy

Summary:

      This is a Phase 1, open-label single-center study to determine the safety of MGD014 in
      participants with human immunodeficiency virus (HIV) infection on stable suppressive
      antiretroviral therapy (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness of participant to provide written informed consent.

          -  HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or
             chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
             confirmed by a licensed Western blot or a second antibody test by a method other than
             the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

          -  On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.

          -  Plasma HIV-1 RNA < 50 copies/mL at two time points in the previous 12 months prior to
             screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive
             time points in the last 24 months.

          -  Adequate organ function based on acceptable laboratory parameters.

        Exclusion Criteria:

          -  Women of childbearing potential defined as any female who has experienced menarche and
             who has not undergone successful surgical sterilization or menopause.

          -  History or other evidence of severe illness, immunodeficiency other than HIV, or any
             other condition that would make the potential participant unsuitable for study.

          -  History or other evidence of any condition or process for which signs or symptoms
             could be confused with reactions to MGD014.

          -  History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months
             prior to screening.

          -  History of clinically significant cardiovascular disease, severe allergic reactions,
             malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2
             years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding
             disorder.

          -  Evidence of active viral, or antifungal treatment within 7 days prior to the
             initiation of study drug

          -  Active, asymptomatic, or suspected COVID-19/SARS-CoV-2 infection.

          -  Active, untreated syphilis.

          -  Use of blood products, cytokine therapy, growth-stimulating factors, cytotoxic
             chemotherapy or investigational therapy within 90 days.

          -  Current use of the antivirals maraviroc and/or enfuvirtide.

          -  Any vaccination with exception of flu vaccine within 30 days of screening.