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
    We 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:

    Magdalena E Sobieszczyk, MD, MPH
    Pfizer and Columbia University Irving Medical Center (CUIMC) are conducting a trial to learn about the safety and effectiveness of an experimental COVID-19 treatment, nirmatrelvir co-packaged with ritonavir, for children with COVID-19 that are at risk of the infection getting worse. Nirmatrelvir/ritonavir has been shown to be effective in fighting SARS-CoV-2 (the virus that causes COVID-19) in laboratory experiments and has been previously evaluated for safety in Phase 1 trials with healthy participants. The US FDA has granted Emergency Use Authorization (EUA) to nirmatrelvir/ritonavir for...
  • Principal Investigator:

    Michael T Yin, MD
    We 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:

    Michael T Yin, MD
    Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is asleep and is also thought to increase the body's natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body's immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts. The purpose of this...
  • Principal Investigator:

    Magdalena E Sobieszczyk, MD, MPH
    We are looking for individuals 18 to 60 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, MPH
    We are looking for individuals 18 to 60 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, MPH
    The HIV Vaccine Trials Network (HVTN) and Columbia University Irving Medical Center (CUIMC) are conducting a study to learn about the safety and effectiveness of an experimental HIV vaccine. The study vaccine is a protein vaccine called N332-GT5 gp140. It includes a manmade protein that looks like a protein found on the outside of HIV. The study vaccine is given with an adjuvant called SMNP. Adjuvants are products that help alert the immune system to have a stronger response. Researchers hope that the immune system will respond by making antibodies and T-cells that could recognize and fight...
  • Principal Investigator:

    Magdalena E Sobieszczyk, MD, MPH
    The HIV Vaccine Trials Network (HVTN) and Columbia University Irving Medical Center (CUIMC) are conducting a study to learn about the safety and effectiveness of an experimental HIV vaccine. The study vaccine is a protein vaccine called N332-GT5 gp140. It includes a manmade protein that looks like a protein found on the outside of HIV. The study vaccine is given with an adjuvant called SMNP. Adjuvants are products that help alert the immune system to have a stronger response. Researchers hope that the immune system will respond by making antibodies and T-cells that could recognize and fight...
  • Principal Investigator:

    Magdalena E Sobieszczyk, MD, MPH
    The HIV Vaccine Trials Network (HVTN), Division of AIDS (DAIDS), and Columbia University Irving Medical Center (CUIMC) are conducting a trial to learn about the safety and effectiveness of a new experimental HIV vaccine. The goal is to understand if the study products are safe to use in people living with HIV, and whether they can get the study products without being too uncomfortable. We also want to understand how people's immune systems respond to the study products, and whether stopping HIV medications changes these immune responses. There will be 2 groups in this study. Both groups will...
  • Principal Investigator:

    Michael T Yin, MD
    We are doing a research study to find out if Long-Acting Injectable anti-HIV medications will be more successful than standard pills for people who have a hard time taking their HIV pills. If you are over the age of 18 years old, have been prescribed HIV medications but have had difficulty getting undetectable viral load (when the levels of virus in the bloodstream are so low that they can't be measured), you may be eligible. You may receive up to $1100 for the first 5 months of participation. Contact us to find out more about this study.

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