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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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 44 → 108 locationsv43
  2. Study sites: 108 to 44 Completion date: Dec 31, 2025 to Dec 31, 2029v42 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2029
  3. Site details revised at 2 of 108 sitesv41
  4. Completion date: Dec 31, 2026 to Dec 31, 2025 Site details revised at 31 of 108 sitesv40 Show 1 more changeShow less
    • Site details revised at 31 of 108 sites
  5. Re-verified, no change to tracked fieldsv39
Show 37 earlier versionsHide 37 earlier versions
  1. Completion date: Feb 8, 2024 to Dec 31, 2026v38
  2. 3 versions Re-verified since Nov 21, 2022, no change to tracked fieldsv35-v37
  3. Site details revised at 12 of 108 sitesv34
  4. 2 versions Re-verified since Sep 22, 2022, no change to tracked fieldsv32-v33
  5. Site details revised at 1 of 108 sitesv31
  6. Site details revised at 16 of 108 sitesv30
  7. Completion date: Jul 7, 2022 to Feb 8, 2024 Site details revised at 1 of 108 sitesv29 Show 1 more changeShow less
    • Site details revised at 1 of 108 sites
  8. 2 versions Re-verified since Dec 14, 2020, no change to tracked fieldsv27-v28
  9. Site details revised at 1 of 108 sitesv26
  10. Study sites: 107 to 108v25
  11. Re-verified, no change to tracked fieldsv24
  12. Study sites: 108 to 107 Publications: details revised at 1 of 12 entriesv23 Show 1 more changeShow less
    • Publications: details revised at 1 of 12 entries
  13. Enrollment target: 628 to 631 Secondary endpoints: 64 to 63 · Site details revised at 11 of 108 sitesv22 Show 2 more changesShow less
    • Secondary endpoints: 64 to 63
    • Site details revised at 11 of 108 sites

    See this version in full on ClinicalTrials.gov ↗

  14. Phase: Phase 2/3 to Phase 3 Results first posted: Oct 29, 2019 · Primary endpoint revised · Enrollment target: 631 to 628 · 2 morev21 Show 5 more changesShow less
    • Results first posted: Oct 29, 2019
    • Primary endpoint revised
    • Enrollment target: 631 to 628
    • Study sites: 131 to 108
    • Secondary endpoints: 43 to 64

    See this version in full on ClinicalTrials.gov ↗

  15. Phase: Phase 3 to Phase 2/3 Primary endpoint revised · Study sites: 112 to 131 · Secondary endpoints: 40 to 43v20 Show 3 more changesShow less
    • Primary endpoint revised
    • Study sites: 112 to 131
    • Secondary endpoints: 40 to 43

    See this version in full on ClinicalTrials.gov ↗

  16. Primary endpoint revised Enrollment target: estimated 570 to confirmed 631 · Primary completion date changed from estimate of Sep 6, 2018 to Aug 30, 2018 · Completion date: Jul 14, 2022 to Jul 7, 2022 · 3 morev19 Show 6 more changesShow less
    • Enrollment target: estimated 570 to confirmed 631
    • Primary completion date changed from estimate of Sep 6, 2018 to Aug 30, 2018
    • Completion date: Jul 14, 2022 to Jul 7, 2022
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 33 to 40
    • Site details revised at 1 of 112 sites

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv18
  18. Primary completion date: Aug 10, 2018 to Sep 6, 2018 Completion date: Jun 17, 2022 to Jul 14, 2022v17 Show 1 more changeShow less
    • Completion date: Jun 17, 2022 to Jul 14, 2022
  19. 6 versions Re-verified since Jun 15, 2017, no change to tracked fieldsv11-v16
  20. Trial status: Recruiting to Active, Not Recruiting Study sites: 78 to 112 · Primary completion date: Aug 2018 to Aug 10, 2018 · Completion date: Jul 2022 to Jun 17, 2022 · 1 morev10 Show 4 more changesShow less
    • Study sites: 78 to 112
    • Primary completion date: Aug 2018 to Aug 10, 2018
    • Completion date: Jul 2022 to Jun 17, 2022
    • Start date: Oct 2016 to Oct 27, 2016
  21. Study sites: 34 to 78v9
  22. Re-verified, no change to tracked fieldsv8
  23. Study sites: 33 to 34v7
  24. Study sites: 30 to 33 Completion date: Jun 2022 to Jul 2022v6 Show 1 more changeShow less
    • Completion date: Jun 2022 to Jul 2022
  25. Study sites: 25 to 30 Primary completion date: Jul 2018 to Aug 2018 · Completion date: May 2022 to Jun 2022v5 Show 2 more changesShow less
    • Primary completion date: Jul 2018 to Aug 2018
    • Completion date: May 2022 to Jun 2022
  26. Study sites: 23 to 25v4
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 16 to 23v3 Show 1 more changeShow less
    • Study sites: 16 to 23
  28. Enrollment target: 620 to 570 Study sites: 0 to 16v2 Show 1 more changeShow less
    • Study sites: 0 to 16
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02938520
Lead Sponsor ViiV Healthcare
Collaborators: Janssen Pharmaceuticals, GlaxoSmithKline
Conditions HIV Infections
Enrollment 631 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov