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
Public ClinicalTrials.gov record NCT02951052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02951052
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 618 participants
Conditions and interventions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2016
- Primary completion
- May 28, 2018
- Completion
- Dec 30, 2029
- Last update posted
- Jul 7, 2026
2016 – 2029
United States locations
- U.S. sites
- 36
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Phoenix | Arizona | 85015 | — |
| GSK Investigational Site | Bakersfield | California | 93301 | — |
| GSK Investigational Site | Long Beach | California | 90813 | — |
| GSK Investigational Site | Los Angeles | California | 90036 | — |
| GSK Investigational Site | Los Angeles | California | 90069 | — |
| GSK Investigational Site | Palm Springs | California | 92264 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | San Francisco | California | 94110 | — |
| GSK Investigational Site | Denver | Colorado | 80246 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | — |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | — |
| GSK Investigational Site | Sarasota | Florida | 34237 | — |
| GSK Investigational Site | Vero Beach | Florida | 32960 | — |
| GSK Investigational Site | Macon | Georgia | 31201 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Boston | Massachusetts | 02129 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Omaha | Nebraska | 68198 | — |
| GSK Investigational Site | Buffalo | New York | 14201 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7064 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267-0405 | — |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Houston | Texas | 77098 | — |
| GSK Investigational Site | Annandale | Virginia | 22003 | — |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02951052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02951052 live on ClinicalTrials.gov.