ViiV Healthcare has launched the new CUSTOMIZE trial to identify and assess approaches for implementing its once-monthly injectable HIV treatment, cabotegravir (ViiV Healthcare) plus rilpivirine (Janssen), into clinical practice.
As part of the one-year trial, a ViiV Healthcare team will collaborate with clinical staff at a variety of sites across the US.
The company intends to determine the most practical approach to implementing a monthly injectable regimen, including ways to address the increased clinic visits frequency.
The CUSTOMIZE trial is currently enrolling patients at various medical clinics in nine US cities of Sacramento, Dallas, Kansas City, Jackson, Detroit, Washington DC, Atlanta, Jacksonville, and Miami.
Participating sites will be provided with educational items, training aids, treatment and resource planning tools, appointment reminders, and patient-facing materials.
The facilities can choose if or how to use these materials and may also develop their own resources.
Throughout the study, ViiV Healthcare will enable surveys and interviews with the physicians, nurses, administrators, and patients. The aim is to share best approaches and identify challenges and facilitators to the delivery of the treatment.
ViiV Healthcare Global Medical Affairs head Harmony Garges said: “With the CUSTOMIZE study, ViiV Healthcare is aiming to identify and evaluate different approaches to implementing a monthly injectable HIV treatment in the real world, which can be different from the controlled setting of a clinical trial.
“Experts believe effective implementation of HIV treatment could have the greatest contribution towards ending the HIV epidemic and we believe this study is an important step towards that goal.”
The company submitted an application to the US regulatory agency this April seeking approval for the two-drug regimen of cabotegravir and rilpivirine to treat HIV-1 infection.
This regimen is designed for adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. In June, the treatment secured priority review designation from the FDA.