Clinical Trials

The clinical activities of ADARC are now part of the CUIMC Department of Infectious Diseases.

We are now conducting a clinical trial of a unique monoclonal antibody that has one arm that attaches to cells that have the receptor required for HIV to enter the cell, the CD4 receptor, and has another arm that attaches to a very well conserved portion of the HIV envelope. This is called a bispecific antibody because it binds to two regions. It is very potent and active against a broad range of HIV virus variants because it is designed to put the antibody at the precise location where it is needed.

The clinical trial is a Phase 1 study led by Dr. David Ho, the study Principal Investigator, and Dr. Magda Sobieczcyk, the CUIMC clinical trial Principal Investigator. The bispecific antibody is given as a single infusion and is recruiting HIV infected and uninfected individuals. To date a total of 42 subjects of a total of 57 have been given the monoclonal antibody infusion in increasing doses safely. Eligible participants are expected to complete 11 visits over 168 days of participation.

  • Principal Investigator:

    Magdalena E Sobieszczyk, MD, MPH
    Do you identify as a woman or transgender person, or do you have a non-binary gender identity? Has a medical provider ever diagnosed you with a sexually transmitted infection or recommended PrEP/another HIV prevention method? We are conducting a study to understand attitudes and preferences regarding HIV prevention methods among people who do not have HIV. The study involves taking online surveys. Some surveys are compensated. Please reach out if you are interested in hearing more about the study.
  • Principal Investigator:

    Magdalena E Sobieszczyk, MD, MPH
    The purpose of this study is to look at whether these study drugs improve the bodys response to human immunodeficiency virus (HIV) in people with HIV (PWH) who started antiretroviral therapy (ART) early after getting HIV-1. The study treatments we are investigating are a study treatment vaccine, a study drug called vesatolimod (VES), and two broadly neutralizing antibodies (bNAbs; antibodies are natural proteins that the body makes in response to an infection), called GS-5423 and GS-2872. None of these experimental products has been approved by the US FDA except to be used in this research...
  • Principal Investigator:

    Michael T Yin, MD
    This research study is being conducted to see if HIV antiretroviral medicines that you are taking continue to work well in transgender women and other individuals identifying as female or transfeminine, but with male sex assigned at birth (referred to as transgender) when taken with feminizing hormone therapy (FHT), also known in this study as estradiol. You will receive estradiol as FHT. FHT is used by some transgender women as part of their gender-affirming care. This study will also assess if estradiol levels in blood vary between boosted and unboosted HIV medicines when transgender women...

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