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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (113 Sites)
Showing the first 25 of 113 sites.
- GSK Investigational Site — Birmingham, Alabama
- GSK Investigational Site — Phoenix, Arizona
- GSK Investigational Site — Bakersfield, California
- GSK Investigational Site — Long Beach, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Los Angeles, California
- GSK Investigational Site — Palm Springs, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — San Francisco, California
- GSK Investigational Site — Denver, Colorado
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Fort Lauderdale, Florida
- GSK Investigational Site — Ft. Pierce, Florida
- GSK Investigational Site — Sarasota, Florida
- GSK Investigational Site — Vero Beach, Florida
- GSK Investigational Site — Macon, Georgia
- GSK Investigational Site — Chicago, Illinois
- GSK Investigational Site — Boston, Massachusetts
- GSK Investigational Site — Detroit, Michigan
- GSK Investigational Site — St Louis, Missouri
- GSK Investigational Site — Omaha, Nebraska
- GSK Investigational Site — Buffalo, New York
- GSK Investigational Site — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Infection, Human Immunodeficiency Virus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.