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NCT02951052 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
A Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 618
- Enrollment target
- 20
- Study locations
NCT02951052: Active Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT02951052 is a Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 618 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02951052, a Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 618 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. 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 with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.
Primary Outcome
Number of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA m
Conditions Studied
Interventions
- DRUG Cabotegravir (CAB) tablet
- DRUG Rilpivirine (RPV) tablet
- DRUG Cabotegravir - Injectable Suspension (CAB LA)
- DRUG Rilpivirine - Injectable Suspension (RPV LA)
- DRUG 2 NRTIs plus an INI, NNRTI, or PI
Study Locations (20)
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
- GSK Investigational Site - San Francisco
- GSK Investigational Site - San Francisco
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Sarasota
- GSK Investigational Site - Vero Beach
District of Columbia
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
Alabama
- GSK Investigational Site - Birmingham
Arizona
- GSK Investigational Site - Phoenix
Colorado
- GSK Investigational Site - Denver
Georgia
- GSK Investigational Site - Macon
Illinois
- GSK Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2016-10-28 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
What the registry record for NCT02951052 still lists
NCT02951052 is an interventional study that assigns participants to a tested intervention. The registered 618 participants enrollment target is mid-sized for trials with a published cap, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (39% higher).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cabotegravir (CAB) tablet is the first listed.
NCT02951052 names 20 study sites across 9 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02951052 about?
NCT02951052 is a clinical study titled "Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults". The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain...
What is the current status of trial NCT02951052?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2016-10-28. Estimated completion is 2029-12-31.
What conditions does trial NCT02951052 study?
This clinical trial studies the following conditions: HIV Infections, Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT02951052?
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), 2 NRTIs plus an INI, NNRTI, or PI (DRUG).
Who is sponsoring clinical trial NCT02951052?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02951052 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02951052's enrollment target sits among peer trials
618 49th of 542 higher than 494 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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