Institute for Global Health



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. 

Links to other research

Other research from the UCL Centre for Clinical Research in Infection and Sexual Health

Other research from IGH on Randomised Controlled TrialsHIV and Treatment

More of IGH's Global research