ICAP has begun efforts to evaluate the safety and acceptability of a new injectable drug for potential use as pre-exposure prophylaxis (PrEP) for HIV prevention. Long-acting rilpivirine, which will be assessed in healthy women without HIV infection, offers promise as an injectable drug that would be used every several weeks to prevent women from getting HIV infection.
Funded by the National Institute of Allergy and Infectious Diseases (NIAID), and led by the “HIV Prevention Trials Network”:http://www.hptn.org/, the two-year multicenter study, HPTN 076, is one of the first to test an injectable antiretroviral drug as an HIV prevention method. Use of a long-acting, injectable drug, if shown to be safe and acceptable, could help overcome the challenge of frequent oral dosing with Truvada, the currently available drug approved for PrEP in the US.
“This is an important opportunity to investigate a new, long-term HIV prevention intervention possibility,” said Dr. Jessica Justman, ICAP senior technical director and lead site investigator at the “Bronx Prevention Center”:https://icap.columbia.edu/where-we-work/united-states, where the study will be conducted. “If proven effective, this trial has the potential to expand on current prevention options.”
The Bronx Prevention Center is one of four research sites—two in sub-Saharan Africa (South Africa and Zimbabwe) and two in the United States—that will enroll women for the study. The participants will receive six sets of injections over a 10-month period and be followed by the research staff for eight months beyond the last injection. The study is being conducted in collaboration with PATH and Janssen Sciences Ireland UC.