Injectable Cabotegravir + Rilpivirine for HIV
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does require participants to switch from their current HIV treatment to the study medications. You should discuss your specific situation with the study team.
What data supports the effectiveness of the injectable drug Cabotegravir + Rilpivirine for HIV?
Is the injectable treatment of Cabotegravir and Rilpivirine safe for humans?
The injectable treatment of Cabotegravir and Rilpivirine has been shown to be generally safe in humans, with most people finding the injections acceptable despite common injection-site reactions (like pain or swelling where the shot is given). Clinical trials have demonstrated that this treatment is as safe as some oral alternatives, but there are still questions about managing missed doses and interactions with other drugs.12346
How is the drug cabotegravir and rilpivirine unique for treating HIV?
Cabotegravir and rilpivirine are unique because they are the first long-acting injectable drugs for HIV treatment, allowing patients to receive injections every 4 to 8 weeks instead of taking daily pills. This can be especially helpful for people who have trouble sticking to a daily medication schedule.12346
What is the purpose of this trial?
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) 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, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B\*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week \[-20\] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA \<50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.
Research Team
GSK Clinical Trials
Principal Investigator
ViiV Healthcare
Eligibility Criteria
Adults with HIV-1 who haven't been treated for it before can join this trial. They must have a certain level of virus in their blood and be able to consent to the study's rules. Women can't be pregnant or breastfeeding, and everyone must meet specific contraception requirements. People with severe allergies to study drugs, serious health conditions, or those at risk of suicide are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive ABC/DTG/3TC for 20 weeks to achieve virologic suppression
Maintenance
Participants are randomized to either continue ABC/DTG/3TC or switch to oral CAB + RPV for 4 weeks, followed by monthly CAB LA + RPV LA injections
Extension
Participants who complete Week 100 and remain virologically suppressed may opt into the Extension Phase with continued monthly injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cabotegravir
- Rilpivirine
Cabotegravir is already approved in European Union, United States, Canada, Japan for the following indications:
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViiV Healthcare
Lead Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE Business School
John (Jack) Lawrence
Janssen Pharmaceuticals
Chief Medical Officer since 2023
MD from University of Virginia School of Medicine
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School