Today, Wistar announces that Professor Luis J. Montaner, D.V.M, D.Phil., has received a four-year, $6.2 million grant to lead a clinical trial that seeks to "drain the viral reservoir" of the HIV-1 virus in patients with HIV/AIDS. The randomized trial, conducted with partners at the University of Pennsylvania Health System and Philadelphia FIGHT, will treat patients currently on antiretroviral therapy with a form of interferon, a modified form of an antiviral chemical produced by the human immune system and already clinically available for treating other viruses. The trial represents the largest randomized clinical study ever designed to deplete the viral reservoir in patients, a necessary first step on the path to a cure.
This clinical trial builds upon a small-scale study previously conducted by Montaner that led to dramatically decreased viral loads in almost half of the 20 patients that took part in the trial. Unlike the pilot study, this trial will look to see what happens when patients take interferon while remaining on their antiretroviral therapies. The new trial, which is due to recruit patients shortly, is also larger and consists of three patient groups or "arms." Volunteers in the control arm of the study will remain on their normal antiretroviral regimen and not receive interferon, while volunteers in the two experimental arms will each receive interferon in addition to their current drug regimens. One of these experimental groups will also interrupt their current antiretroviral therapy regimen for a four-week period to see if the interruption will flush more virus out of hiding where it can be destroyed by the now-boosted immune system.