The Wistar Institute, in partnership with Philadelphia FIGHT, the University of Pennsylvania, University of California and Merck, is undertaking a trial study based on a therapeutic strategy that has already shown promise at reducing HIV-1 virus levels.
Dr. Luis J. Montaner, a professor at The Wistar Institute and director of Wistar’s HIV-1 Immunopathogenesis Lab, and collaborators received a four-year, $6.2-million grant from the National Institute of Allergy and Infectious Disease of the National Institutes of Health to support the study.
Montaner said his team has been pursuing the grant for several years.
“There is a lot of preamble before the award is given,” he said. “We have been chasing the opportunity to do this study since 2011.”
The study is based on a prior pilot trial in which a protein called interferon-alpha was shown to reduce persistent HIV-1 in patients being treated with antiretroviral therapy.
The grant will pay for the management of the clinical and administrative expenses of the study and for laboratory follow-up, which will allow researchers to calculate the study’s outcome.
Montaner said the team will perform an initial evaluation of the study in mid-2016, and it will be finalized in 2018.
The trial calls for a 20-week treatment of pegylated interferon, which is a modified form of the antiviral chemical produced by the human immune systems.
In a previous 2011 study, 20 participants were taken off antiretroviral therapy for six months while they received treatment with pegylated interferon. More that 50 percent of participants saw a reduction in the circulating HIV reservoirs. An ongoing second pilot, involving 25 subjects, is also underway.
The new trial will involve 54 volunteer subjects, who will be split into three study groups, two of which will receive pegylated interferon-alpha in addition to the ongoing antiretroviral therapy. One of these two will be taken off their current antiretroviral-therapy regimen for four weeks. The third group will continue the antiretroviral therapy and not be given the interferon-alpha.
Dr. Jay R. Kostman, clinical professor of medicine in the Division of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania, will oversee clinical supervision.
Montaner said the study could have groundbreaking implications.
“It is the largest study and first study with a randomized approach to a cure,” Montaner explained. “When opportunities open up, there will be more investments and studies in the future. There has been discussion that these studies need to happen. Nationally, there will be attention in terms of how we do.”
Wistar Institute and Philadelphia FIGHT have had a long history of collaborating. FIGHT executive director Jane Shull said the two began working together in 1994.
Shull added the study is a large step forward in cure research.
“This is a groundbreaking and unique study that might be a step towards a cure. There are other people working for a cure, but you couldn’t talk about a cure 10 years ago,” she said. “I think in 10 years there will be a cure and this will be over.”
For more information or to learn about participating, visit www.wistar.org.
The AIDS Policy Project is hosting a town meeting on AIDS cure research at 7 p.m. Feb. 5 at William Way LGBT Community Center, 1315 Spruce St. Speakers will include Montaner and Dr. Pablo Tebas, AIDS researcher and professor of medicine at the Hospital of the University of Pennsylvania.