A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

• Status: Active, not recruiting
• Trial end date: 2023-06-26

Summary

Human immunodeficiency virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) is a worldwide epidemic that continues to grow significantly causing new infections and related deaths per year. Chronic HIV infection in adults continues to be characterized by increased development and transmission of resistant virus and issues associated with long-term toxicity of antiretroviral therapy (ART). The current paradigm in the treatment of HIV involves life-long therapy with multiple antiretrovirals (ARVs). This dependency on medical therapy requires a need for continuous improvement on the durability, tolerability and convenience of all antiretroviral classes. This is a Phase IIIb, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study (SOLAR: Switch Onto Long Acting Regimen). It is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA administered every 2 months (Q2M) compared with maintenance of BIK. Approximately 654 adult HIV-1 infected participants who are on the stable ARV regimen BIK will be randomized in a 2:1 ratio to either be switched to the CAB LA + RPV LA regimen or continue BIK through 12 months. The study will continue with an Extension Phase after Month 12 Oral Lead-In (OLI) and BIK/Month 11 Direct to Injection (D2I).

BIKTARVY is a registered trademark of Gilead Sciences.

• Phase: Phase 3

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Janssen, LP
• Treatments: Cabotegravir; Rilpivirine