NIAID Renews Weill Cornell Medicine Grant for Advancing Prevention and Treatment Research for HIV

Dr. Gulick leaning against desk in office

Weill Cornell Medicine has received a renewal of a prestigious grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health to continue cutting-edge clinical research into treating and preventing infection with human immunodeficiency virus (HIV).

The research team at the Weill Cornell Medicine-New Jersey Medical School Clinical Trials Unit (WCM-NJMS CTU), led by principal investigator Dr. Roy Gulick, the Rochelle Belfer Professor in Medicine at Weill Cornell Medicine and chief of the Division of Infectious Diseases at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, will receive $19 million in funding over seven years to pursue the research.

“Over the years, we have participated in breakthrough advances in HIV treatment, and more recently, HIV prevention,” Dr. Gulick said. “But there are a number of important, unanswered questions. We look forward to tackling them with our renewed grant.”

The Cornell Clinical Trials Unit (CCTU), one of the first clinical trials units in the United States to conduct HIV/AIDS treatment research, has received funding from NIAID dating back to 1987. As a member of the AIDS Clinical Trials Group and the HIV Prevention Trials Network global collaboratives, the CCTU has participated in many of the significant advancements in HIV treatment and prevention available today. The advancements include combination antiretroviral therapy in a one-pill-per-day format and a prevention strategy known as pre-exposure prophylaxis (PrEP) that is up to 99 percent effective in preventing HIV infection with a pill taken once daily. A new injectable PrEP formulation administered every eight weeks is currently under review by the U.S. Food and Drug Administration.

New York City remains the epicenter of the HIV epidemic in the United States, with 1.4 percent of the population living with HIV. In its most recent partnership with Rutgers-NJMS, the WCM-NJMS CTU consists of three clinical research sites: Weill Cornell Medicine-Uptown, Weill Cornell Medicine-Chelsea and Rutgers-NJMS in Newark. The sites draw from a diverse patient population that is about one-third white, Black and Latino, respectively. They enrolled more than 1,000 participants in a wide variety of HIV treatment and prevention trials during the current grant cycle.

With the renewed grant, the WCM-NJMS team of investigators will pursue clinical research in three areas. They will investigate new drug delivery formats, such as transdermal patches, similar to nicotine patches for smoking cessation, and long-lasting implants under the skin, like those used for birth control. They will continue to test new approaches for treating coinfections that can occur with HIV: Dr. Kristen Marks, an associate professor of medicine in the Division of Infectious Diseases at Weill Cornell Medicine and infectious disease specialist at NewYork-Presbyterian/Weill Cornell Medical Center, will investigate treatments for hepatitis C coinfection; Dr. Timothy Wilkin, a professor of medicine in the division and infectious disease specialist at the medical center, and Dr. Grant Ellsworth, an instructor in medicine, will explore novel strategies for preventing the progression of human papillomavirus infection (HPV); and Dr. Marshall Glesby, a professor of medicine and associate chief of the division and director of the WCM-NJMS CTU, will research ways to reduce and manage side effects associated with HIV treatments. Dr. Glesby will also collaborate with Dr. Carrie Johnston, instructor in medicine, to explore the field of aging and HIV, as over half of the people living with diagnosed HIV in the United States today are 50 years of age or older.

The WCM-NJMS CTU also aims to advance new strategies for HIV cures from the lab into clinical research. Dr. Brad Jones, associate professor of immunology in medicine, Dr. Douglas Nixon and Dr. Lishomwa Ndhlovu, both professors of immunology in medicine are leading the Division of Infectious Diseases’ lab research funded by a separate $28 million grant under the Martin Delaney Collaboratories for HIV Cure Research, the NIH’s flagship program focused on finding an HIV cure. “It has been very challenging to find an HIV cure because even when a patient is doing well clinically, some HIV-infected cells remain,” Dr. Gulick said. “As our lab research team develops new strategies for a cure, we plan to investigate them in clinical research.”

Recognized by the NIH as a clinical trial unit with expert leadership and an established infrastructure for recruiting and managing clinical trials, the NIH recently tapped the WCM-NJMS CTU to participate in COVID-19 clinical research. To date, efforts have included enrolling more than 100 people in the phase 3 study evaluating Moderna Therapeutics’ COVID-19 vaccine and a monoclonal antibody treatment for people with mild to moderate COVID-19 that may prevent or lessen disease progression.

“Clinical research requires a team of people, including investigators, clinical coordinators, lab personnel, data analysts, regulatory managers and more,” Dr. Gulick said. “I’m really proud of our HIV clinical trials research team for pivoting quickly so that we could play an active role in the rapid response to the global COVID-19 pandemic in addition to our HIV research.”

The WCM-NJMS CTU is supported by NIAID with NIH grant number 2 UM1 AI069419-15.

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