ViiV Healthcare said that its team will work with clinical staff at different sites across the US to conduct one-year CUSTOMIZE trial (cabotegravir plus rilpivirine in the US to optimise and measure implementation and experience).
In April this year, the company submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the two-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
Edurant (rilpivirine) is a prescription medicine, which is used with other antiretroviral medicines for the treatment of human immunodeficiency virus-1 (HIV-1) in people 12 years of age and older and who weighs at least 77 lbs (35kg).
ViiV Healthcare global medical affairs head Dr 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.”
At present, the company is recruiting patients in medical clinics in nine US cities, which have been selected to create a representative sample of clinic types.
CUSTOMIZE is a single-arm, multicentre and one-year evaluation study of the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinic practices to provide the once-monthly, injectable regimen of cabotegravir and rilpivirine to appropriate patients living with HIV.
The trial will assess both qualitative and quantitative measures across a range of clinic types, including university hospitals, private and public clinics, with varied geographic and demographic representation.
ViiV Healthcare will help conduct surveys and interviews across the study with the physicians, nurses, administrators and patients to share best practices and detect barriers and facilitators to the successful delivery of monthly injectable HIV treatment. The company plans to reveal the initial results at the end of this year.