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.
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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. 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 questionnaire, and to provide blood, respiratory, and optional stool/rectal swab samples. You will be compensated $50 for... -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHWe 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, MPHWe 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, MPHThe HIV Vaccine Trials Network, Division of AIDS, and Columbia University Irving Medical Center are conducting a trial to learn about the safety and effectiveness of two new experimental HIV vaccines. This is a first-in-human phase 1 clinical trial where we will be testing 2 study vaccines, CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. The goal is to understand if the study products are safe to use in people not 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... -
Principal Investigator:
Magdalena E Sobieszczyk, MD, MPHThe 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, MPHThe 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:
Magdalena E Sobieszczyk, MD, MPHThis trial is testing an experimental treatment for HIV that is called CAB + RPV LA (long-acting cabotegravir and rilpivirine). CAB + RPV LA is a combination of drugs that is used to treat HIV (called antiretroviral therapy ART). It is currently approved in the US for the treatment of people living with HIV who are taking ART and whose viral load is already undetectable. This trial is a Phase 3b study testing whether CAB + RPV LA is effective at reducing HIV viral load to undetectable levels in people who currently have a detectable viral load despite being prescribed oral ART. This trial... -
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.