Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults (NCT03299049)
A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed
🩺 Plain-English Summary (8th-Grade Level)
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.
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 (118 Sites)
Showing the first 25 of 118 sites.
- GSK Investigational Site — Birmingham, Alabama
- GSK Investigational Site — Phoenix, Arizona
- GSK Investigational Site — Bakersfield, California
- GSK Investigational Site — Beverly Hills, California
- GSK Investigational Site — Long Beach, California
- GSK Investigational Site — Los Angeles, 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 — San Francisco, California
- GSK Investigational Site — Torrance, 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 — Augusta, Georgia
- GSK Investigational Site — Macon, Georgia
- GSK Investigational Site — Chicago, Illinois
- GSK Investigational Site — Boston, Massachusetts
💰 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.
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💡 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.