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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
NCT02951052 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02951052
The ClinicalTrials.gov registry entry for NCT02951052 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 618 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02951052 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02951052?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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