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.

  • ARMOR Study: A Study to Follow COVID-19 Antibodies Over Time

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    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.

  • C4671026 - Pfizer Pediatric Paxlovid Study

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    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...

  • COVID-19 Persistence: Understanding the SARS-CoV-2 Virus and Host Factors in People Who Are Recovering From Their Illness (C-PIC)

    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...

  • COVID-19 Treatment Study: ACTIV-2d/A5407

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    The main purpose of this study is to evaluate the ability of an experimental oral drug called S-217622 to improve the health of people with coronavirus disease 2019 (COVID-19). We also want to see if this study drug is safe, and if this study drug can shorten the time you have COVID-19 symptoms, reduce the amount of virus in the body, and prevent hospitalization or death. You will be eligible for this study if you are considered at lower risk for severe COVID-19 and have none of the risk factors that would put you at higher risk of disease progression. Study drug will be either an active...

  • HIV Prevention Study

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    We are looking for HIV-negative individuals 18 to 60 years old who are interested in learning more about HIV prevention 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.

  • HIV Prevention Study

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    We are looking for HIV-negative individuals 18 to 60 years old who are interested in learning more about HIV prevention 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.

  • Long-Acting ART in Non-Adherent Participants

    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.

  • Oral Health and Bone Loss in Women and Men

    Principal Investigator:

    Michael T Yin, MD
    The study is exploring the impact of gender, age, HIV infection, and menopausal status on dental health. The study is open to men and women, ages 35-70.

  • Oral Health and Bone Loss in Women and Men (Healthy Volunteers)

    Principal Investigator:

    Michael T Yin, MD
    The study is exploring the impact of gender, age, HIV infection, and menopausal status on dental health. The study is open to men and women, ages 35-70.

  • Respiratory Syncytial Virus (RSV) Vaccine Study

    Principal Investigator:

    Magdalena E Sobieszczyk, MD
    The main purpose of this study is to evaluate a Respiratory Syncytial Virus vaccine (RSVpreF for short). Respiratory Syncytial Virus, called RSV, is a common type of virus that is a major cause of respiratory infection in all ages, and can result in severe illness in those with health conditions that put them at increased risk of severe RSV and complications. We are doing a study to test the safety of the RSVpreF vaccine, and how well it is tolerated. The study will also test how a person's immune system responds to the vaccines and how much antibody is made after the vaccine. Approximately...

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