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NCT02938520 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 631
- Enrollment target
- 20
- Study locations
NCT02938520 is a Phase 3 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 631 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT02938520, a Phase 3 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 631 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 b
Conditions Studied
Interventions
- DRUG Cabotegravir (CAB) tablet
- DRUG Rilpivirine (RPV) tablet
- DRUG Cabotegravir - Injectable Suspension (CAB LA)
- DRUG Rilpivirine - Injectable Suspension (RPV LA)
- DRUG ABC/DTG/3TC STR - Tablet
Study Locations (20)
Other
- GSK Investigational Site - Aichi
- GSK Investigational Site - Osaka
- GSK Investigational Site - Tokyo
- GSK Investigational Site - Kazan'
- GSK Investigational Site - Kemerovo
- GSK Investigational Site - Krasnodar
- GSK Investigational Site - Lipetsk
- GSK Investigational Site - Moscow
- GSK Investigational Site - Oryol
- GSK Investigational Site - Saint Petersburg
- GSK Investigational Site - Saint Petersburg
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Bellaire
- GSK Investigational Site - Dallas
- GSK Investigational Site - Fort Worth
California
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
Georgia
- GSK Investigational Site - Augusta
- GSK Investigational Site - Macon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 631 participants |
| Start Date | 2016-10-27 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02938520
The ClinicalTrials.gov registry entry for NCT02938520 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 631 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (42% higher). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cabotegravir (CAB) tablet is the first listed.
NCT02938520 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT02938520 about?
NCT02938520 is a clinical study titled "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". 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 t...
What is the current status of trial NCT02938520?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 631 participants. The study started on 2016-10-27. Estimated completion is 2029-12-31.
What conditions does trial NCT02938520 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02938520?
The interventions under investigation include: Cabotegravir (CAB) tablet (DRUG), Rilpivirine (RPV) tablet (DRUG), Cabotegravir - Injectable Suspension (CAB LA) (DRUG), Rilpivirine - Injectable Suspension (RPV LA) (DRUG), ABC/DTG/3TC STR - Tablet (DRUG).
Who is sponsoring clinical trial NCT02938520?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02938520 being conducted?
This trial has 20 study locations across California, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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