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 (NCT02938520)
A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (108 Sites)
Showing the first 25 of 108 sites.
- GSK Investigational Site — Birmingham, Alabama
- GSK Investigational Site — Bakersfield, California
- GSK Investigational Site — Long Beach, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — Aurora, Colorado
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Fort Lauderdale, Florida
- GSK Investigational Site — Orlando, Florida
- GSK Investigational Site — Atlanta, Georgia
- GSK Investigational Site — Augusta, Georgia
- GSK Investigational Site — Macon, Georgia
- GSK Investigational Site — Indianapolis, Indiana
- GSK Investigational Site — Minneapolis, Minnesota
- GSK Investigational Site — Omaha, Nebraska
- GSK Investigational Site — Camden, New Jersey
- GSK Investigational Site — New York, New York
- GSK Investigational Site — Providence, Rhode Island
- GSK Investigational Site — Austin, Texas
- GSK Investigational Site — Bellaire, Texas
- GSK Investigational Site — Dallas, Texas
- GSK Investigational Site — Fort Worth, Texas
- GSK Investigational Site — Longview, Texas
- GSK Investigational Site — Lynchburg, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV Infections
- Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention — Chicago, Illinois
- The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City — New York, New York
- Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults — Birmingham, Alabama
- Clinical Decision Support for PrEP — Los Angeles, California
- Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care — Baltimore, Maryland
- A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV — Las Vegas, Nevada
Explore by condition: All HIV Infections clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.