ICAP at Columbia University is playing a key role in testing the feasibility of a potential breakthrough in the global effort to stop HIV transmission.
The Harlem Prevention Center, one of ICAP’s two clinical research centers in New York, is participating in a multi-site study on combinations of antibodies that could lead to a new prevention option for HIV. The study, HVTN 130/HPTN 089, was developed by the HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) and is funded by the Division of AIDS at the U.S. National Institutes of Health (NIH) through FHI 360 .
“This is the first step toward understanding whether combinations of antibodies are safe and offer effective protection against HIV. Developing a new way to prevent HIV could transform global HIV prevention efforts,” said Cassia Wells, MD, MPH, associate research scientist in ICAP’s Clinical and Training Unit and principal investigator for HVTN 130/HPTN 089 at the Harlem Prevention Center. “This especially resonates in Harlem, which was one of the early epicenters of the HIV crisis and has participated so deeply as a community in driving and shaping the waves of the public health response.”
The antibodies used in this study—PGT121, PGDM1400, 10-1074, and VRC07-523LS—are laboratory-created copies of natural antibodies found in the blood of people living with HIV. These specific antibodies are known to neutralize many different strains of HIV and may be more powerful in combination than alone. This first-in-humans trial will test different combinations of the antibodies to see whether people are able to receive them via intravenous infusion without serious side effects or discomfort, and how people’s bodies respond to the different combinations.
HVTN 130/HPTN 089 is a randomized phase 1 clinical trial, meaning that study participants will be randomly assigned to receive one of the combinations of antibodies being tested. As a phase 1 trial, this study is primarily designed to test the safety and tolerability of receiving the antibodies. Participants will not be exposed to HIV as part of the trial, and they will be counseled on condom use and other methods of HIV prevention to utilize while the trial is ongoing. If the current study determines that the combinations of antibodies can be safely studied in larger groups of people, future trials would then be possible to produce reliable scientific evidence on whether the combinations of antibodies work to prevent HIV.
In total, the study will enroll 27 participants across four sites: ICAP’s Harlem Prevention Center and the Columbia University Vagelos College of Physicians and Surgeons sites in New York, the Vanderbilt University Medical Center site in Nashville, Tennessee, and the Fenway Health site in Boston. Recruitment and enrollment for this 19-month study are projected to begin on August 1, 2019.
Together, ICAP’s Harlem Prevention Center and Bronx Prevention Center have contributed to three other HPTN studies and one combined HVTN/HPTN study, focusing on injectable forms of PrEP (pre-exposure prophylaxis), optimal pill-taking schedules for oral PrEP, and antibody-mediated prevention.
“This study is a critical proof-of-concept trial that could help establish the feasibility of a powerful tool to stop the HIV epidemic in its tracks,” said Sharon Mannheimer, MD, site leader for ICAP’s Harlem Prevention Center and co-chair for the HVTN 130/HPTN 089 protocol. “It’s also a recognition of the excellent standard of research that ICAP reliably achieves through its two centers in New York. We are very proud to be a part of this amazing effort.”
About HVTN and HPTN:
The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) are both international collaborations of scientists, educators, and community members searching for effective ways to prevent HIV. The HVTN focuses on safe and effective HIV vaccines, while the HPTN focuses on other HIV prevention methods such as pre-exposure prophylaxis and treatment as prevention. The HVTN and HPTN are funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH).
A global health leader since 2003, ICAP was founded at Columbia University with one overarching goal: to improve the health of families and communities. Together with its partners—ministries of health, large multilaterals, health care providers, and patients—ICAP strives for a world where health is available to all. To date, ICAP has addressed major public health challenges and the needs of local health systems through 6,000 sites across more than 30 countries. For more information about ICAP, visit: icap.columbia.edu
Photo caption—Header photo: Scanning electromicrograph of an HIV-infected H9 T-cell. Credit: NIAID