ViiV Healthcare has kicked off the CUSTOMIZE trial which aims to identify and evaluate approaches to implementing a once-monthly, injectable treatment for HIV into clinical practice.
A team from ViiV Healthcare will work with clinical staff at diverse practice sites across the US during the one-year study, in which healthcare providers and patients will play an equally important role.
The goal is to find the most practical and efficient ways to implement a monthly injectable treatment regimen if approved, including how to address the increased frequency of clinic visits.
“If approved, the injectable regimen of cabotegravir and rilpivirine would require people living with HIV to receive injections from a healthcare provider every month,” said Richard Elion, Director of Clinical Research at the Washington Health Institute.
“Although some people living with HIV may prefer once monthly visits to their provider, this would be a paradigm shift in the treatment of HIV, and providers may encounter challenges delivering a smooth service.
“The CUSTOMIZE trial will help to generate data that enable medical practices to be well prepared for incorporating this novel approach into the clinic setting.”
In April 2019, ViiV Healthcare submitted a New Drug Application (NDA) to the US FDA for the two-drug regimen of its cabotegravir and Janssen’s rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed.
If approved, the regimen would be the first-ever long-acting, injectable therapy for the treatment of HIV.
The CUSTOMIZE trial is currently enrolling patients in medical clinics in nine US cities that were chosen to create a representative sample of clinic types.