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
Public ClinicalTrials.gov record NCT03299049. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03299049
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,049 participants
Conditions and interventions
Conditions
Interventions
- Cabotegravir Tablets Drug
- Rilpivirine Tablets Drug
- Cabotegravir Injectable Suspension Drug
- Rilpivirine Injectable Suspension 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, 2017 (Actual)
- Primary completion
- Jun 6, 2019 (Actual)
- Completion
- Dec 31, 2029 (Estimated)
- Last update posted
- Aug 22, 2025
2017 – 2029
United States locations
- U.S. sites
- 43
- U.S. states
- 18
- U.S. cities
- 36
| 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 | Beverly Hills | California | 90211 | — |
| GSK Investigational Site | Long Beach | California | 90813 | — |
| GSK Investigational Site | Los Angeles | California | 90027 | — |
| 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 | San Francisco | California | 94118 | — |
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Denver | Colorado | 80246 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20005 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| 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 | 32690 | — |
| GSK Investigational Site | Augusta | Georgia | 30912-3130 | — |
| GSK Investigational Site | Macon | Georgia | 31201 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Boston | Massachusetts | 02129 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55415 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Omaha | Nebraska | 68198 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| 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 | Bellaire | Texas | 77401 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77098 | — |
| GSK Investigational Site | Longview | Texas | 75605 | — |
| 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 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03299049, 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 Aug 22, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03299049 live on ClinicalTrials.gov.