SAN FRANCISCO — As part of a new cooperative agreement from the U.S. Agency for International Development, RTI International and its partners will develop and test the use of a device that when injected can prevent HIV for up to three months.
The five-year award, worth up to $11.6 million is provided by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through USAID.
The Thin-Film Polymer Device for antiretroviral-based HIV prevention could provide those at risk of HIV with three months or more of continuous protection against HIV infection. Because the device is injectable and long-lasting, it offers maximum discretion of use, thus overcoming several of the social and logistical adherence challenges associated with other HIV prevention methods such as a vaginal gels, rings and taking oral medications.
“USAID’s support for the development of this innovative technology could not come at a more opportune time. Several large HIV prevention trials showed us that young and vulnerable people — particularly young women — experience major challenges with using daily prevention products,” said Ariane van der Straten, Ph.D., the project leader and director of the Women’s Global Health Imperative at RTI International. “This technology has the potential to provide end users with a safer and simpler long-acting HIV preventative that circumvents most of the adherence challenges faced by user-controlled methods to date.”
The anti-HIV technology operates systemically and should provide protection from several routes of HIV exposure, including vaginal, rectal, and parenteral for both women and men.
The injection can be administered by lower-skilled staff, facilitating access in resource-limited settings. It is a biodegradable product, which alleviates the need for an extra clinic visit to remove the device after the therapeutic is depleted.
Nevertheless, if needed, the device can be removed after insertion; therefore, unlike injectable long acting antiretroviral technologies under investigation, this method is reversible if the patient experiences serious adverse side effects.
Through this award, RTI, along with key collaborators from the University of California, San Francisco and Magee-Womens Research Institute and Foundation (MRWIF) at the University of Pittsburgh, will develop a novel sustained-release delivery system for different classes of antiretroviral agents, that improves on the effectiveness, acceptability, usage and accessibility of existing microbicide and Pre-Exposure Prophylaxis delivery systems.
“We are very excited to further develop our drug delivery technology with RTI and MWRIF to address this critical global need,” said Tejal Desai, Ph.D., professor of bioengineering at University of California, San Francisco. “The USAID support will enable an innovative multidisciplinary approach to solve this challenge.”
The team also will carry out product pilot manufacturing and scale-up for clinical studies, and conduct a Phase I clinical program in healthy human volunteers with a lead antiretroviral-device combination.
“The MRWIF at the University of Pittsburgh is excited to collaborate with RTI and UCSF on the development of an implantable antiretroviral device for HIV prevention – this technology has the potential to reduce rates of HIV infection in multiple at risk populations,” said Ian McGowan, M.D., Ph.D., professor of Medicine at the University of Pittsburgh.
The U.S. Agency for International Development administers the U.S. foreign assistance program providing economic and humanitarian assistance in more than 80 countries worldwide.