A Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants.
Project Summary
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if HIV-infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC).
FLAIR is a Phase 3, open label, randomised controlled trial in antiretroviral therapy (ART)-naïve adult participants.
This study is designed to demonstrate the non-inferior antiviral activity of switching to the two drug regimen of CAB LA 400 mg + RPV LA 600 mg. CAB is given every 4 weeks. The comparator is remaining on ABC/DTG/3TC. The primary endpoint is at 48 weeks.
Key Project Information
Dates: November 2016 - (ongoing)
UCL lead/Principal Investigator: Dr Sarah Pett
Lead organisation: Viiv Healthcare/UCL
Partners: Central and North West London NHS Foundation Trust
Location: Global
Funding: Gilead Sciences
Contact: mmc-research-cnwl@nhs.net
Website: https://clinicaltrials.gov/ct2/show/NCT02938520
- Research Team
Dr Alejandro Arenas-Pinto
Alessandro Borca
Dr Lewis Haddow
Deidre Sally