Montaner, together with international delegations, attended the April 4 launch in Ho Chi Min City.
On April 4, tucked in a courtyard at the Go Vap District Health Center in Vietnam’s Ho Chi Min City, Dr. Luis J. Montaner joined local and international dignitaries to mark the start of the AMOHI Clinical Trial.
Spearheaded by Montaner, who leads Wistar’s HIV Research Program, the study is a consortium that includes Wistar, National Institute of Drug Abuse, University of Pennsylvania, IMEA Paris, Pasteur Institute, Ho Chi Minh City CDC and industry partners in Ireland and India. Together, they will investigate the impact of opioid use disorder (OUD) and medications for opioid use disorder (MOUDs) on immune recovery in response to antiretroviral therapy (ART) in HIV-infected people.
The launch was several years in the making. In 2019, The Wistar Institute received two major grants totaling more than $12 million from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to fund the clinical trial in Vietnam and study related topics in Philadelphia. As COVID emerged, however, and nearly all services, including international travel, ground to a halt, the launch of the program was put on hold. Now, the effort is officially underway.
The overarching goal of the research is to investigate the role of opioid receptor involvement in modulating the levels of immune activation, retention on treatment and effects of different classes of MOUDs as first study to compare strategies head-to-head, in people living with HIV. Effectively controlling immune activation after ART in persons taking MOUDS can directly impact health and mortality.
Enrollment for the 3-year study opened on January 30, with a total of 225 planned enrollees, and is expected to close on February 1, 2026. The study will assess three different treatments to determine which is best for opioid use dependent individuals living with HIV: methadone, buprenorphine/naltrexone, and extended-release naltrexone.
“We will test the impact of a previously unknown interaction between substance abuse, HIV infection and MOUDs that may determine health outcomes only if the right MOUD medication is chosen,” explained Dr. Montaner, D.V.M., D.Phil., Herbert Kean, M.D., Family Professor and director of the HIV-1 Immunopathogenesis Laboratory at Wistar’s Vaccine & Immunotherapy Center.
“We expect the results of this major collaborative effort, which has its hub in Philadelphia, to have broad clinical implications in informing the best pharmacologic strategy for the management of opioid use disease in HIV-infected people starting ART,” said Montaner. “This is directly relevant in light of the opioid epidemic ongoing in our nation and will help ensure that the right medications are used for both HIV and OUD, with the ultimate objective of saving lives in the future.”