FLAIR

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.