(Alliance News) - GlaxoSmithKline PLC on Monday said ViiV Healthcare has commenced a trial to identify and evaluate approaches to implementing a once-monthly, injectable treatment for HIV into clinical practice.
ViiV Healthcare is a specialist HIV company majority owned by GSK, with Pfizer Inc and Shionogi Ltd as shareholders.
During the one-year study, GSK said a team from ViiV will work with clinical staff to find the most practical and efficient ways to implement a monthly injectable treatment regimen, including how to address the increased frequency of clinic visits.
The trial is currently enrolling patients in medical clinics in nine US cities that were chosen to create a representative sample of clinic types, including university hospitals, private and public clinics in rural, suburban and urban areas.
In April, ViiV submitted a new drug application to the US Food & Drug Administration for the two-drug regimen of cabotegravir and rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
If approved, the regimen would be the first-ever long-acting, injectable therapy for the treatment of HIV.
"With daily oral antiretroviral therapies, physicians see their patients once or twice per year. If approved, the injectable regimen of cabotegravir and rilpivirine would require people living with HIV to receive injections from a healthcare provider every month," explained Richard Elion, director of Clinical Research at the Washington Health Institute.
"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," added Harmony Garges, head of Global Medical Affairs at ViiV.
GSK shares were trading 0.7% lower on Monday in London at 1,625.00 pence each.