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, MPHWe want to assess the baseline and cumulative seroprevalence of SARS-CoV-2 using serological and molecular assays. We will also administer a survey. Findings from this study will inform; 1) our understanding of changing epidemiology of COVID-19; 2) use of serological assays and testing algorithms, and 3) approaches to managing psychosocial stress in the community. -
Principal Investigator:
Michael T Yin, MDWe are seeking volunteers who have been diagnosed with COVID-19 by a healthcare provider or by lab testing. We are also looking for volunteers who have never tested positive for COVID-19 and have not received a COVID-19 vaccine. The study, also known as C-PIC, will be looking at antibody levels and how long the virus remains in the body. We are also studying the long-term complications that can occur after recovery from an acute COVID-19 infection, commonly referred to as long-COVID, long haul COVID, and post-acute sequelae of SARS-CoV-2 (PASC). At each visit, you will be asked to complete a... -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHWe are looking for individuals 18 to 65 years old who are interested in learning more about HIV prevention and biomedical research studies. We will ask you to complete a brief questionnaire to find out if we can schedule you for a one-on-one, 1.5-hour education visit to learn about the research we do. The education visit will help you decide if you want to participate in one of our studies. You will be compensated for the visit. Your responses to this questionnaire will be kept strictly confidential. -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHWe are looking for individuals 18 to 65 years old who are interested in learning more about HIV prevention and biomedical research studies. We will ask you to complete a brief questionnaire to find out if we can schedule you for a one-on-one, 1.5-hour education visit to learn about the research we do. The education visit will help you decide if you want to participate in one of our studies. You will be compensated for the visit. Your responses to this questionnaire will be kept strictly confidential. -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHThis clinical research study is seeking healthy individuals ages 18 to 65 who do not have HIV to help researchers understand how the body's immune system responds to three investigational antibodies (VRC07-523LS, PGT121.414.LS, and PGDM1400LS) against HIV when given in different combinations and doses. This is a Phase 2 study, which means that the combination of these antibodies has been previously studied in humans at similar or higher doses than what would be given in this study. The study involves two intravenous (IV) infusions of the study antibodies at two different timepoints; the first... -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHWe are looking for individuals over 18 years old who are interested in learning more about COVID-19 prevention research studies. We will ask you to complete a brief questionnaire to find out if you may be eligible for one of our studies. We can then schedule a phone call, teleconference, or in-person education visit so you can learn about the research we do and decide if you want to participate in one of our studies. Your responses to this questionnaire will be kept strictly confidential. -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHDo 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, MPHThe main purpose of this study is to look at whether experimental study drugs are safe, whether your body can handle the effects, and whether these study drugs improve the body's response to human immunodeficiency virus (HIV) in people with HIV (PWH) who started antiretroviral therapy (ART) early after getting HIV-1. The study treatments include: a treatment vaccine (not a preventative vaccine), a 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...