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NCT03299049 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 3
- Development phase
- 1,049
- Enrollment target
- 20
- Study locations
NCT03299049: Active Phase 3 study of HIV Infections, sponsored by ViiV Healthcare.
NCT03299049 is a Phase 3 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 1,049 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (136% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03299049, a Phase 3 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,049 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of CAB LA+RPV LA Q8W compared to CAB LA + RPV LA Q4W regimen over 48 weeks in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all randomi
Conditions Studied
Interventions
- DRUG Cabotegravir Tablets
- DRUG Rilpivirine Tablets
- DRUG Cabotegravir Injectable Suspension
- DRUG Rilpivirine Injectable Suspension
Study Locations (20)
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Beverly Hills
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- 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
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Torrance
District of Columbia
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
- GSK Investigational Site - Washington D.C.
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Ft. Pierce
- GSK Investigational Site - Sarasota
Alabama
- GSK Investigational Site - Birmingham
Arizona
- GSK Investigational Site - Phoenix
Colorado
- GSK Investigational Site - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,049 participants |
| Start Date | 2017-10-27 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03299049 still lists
NCT03299049 is an interventional study that assigns participants to a tested intervention. Its 1,049 participants enrollment target places it among the larger protocols in the corpus, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (136% higher).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Cabotegravir Tablets is the first listed.
NCT03299049 names 20 study sites across 6 states, led by California, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT03299049 about?
NCT03299049 is a clinical study titled "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". 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 p...
What is the current status of trial NCT03299049?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,049 participants. The study started on 2017-10-27. Estimated completion is 2029-12-31.
What conditions does trial NCT03299049 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT03299049?
The interventions under investigation include: Cabotegravir Tablets (DRUG), Rilpivirine Tablets (DRUG), Cabotegravir Injectable Suspension (DRUG), Rilpivirine Injectable Suspension (DRUG).
Who is sponsoring clinical trial NCT03299049?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03299049 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.
Learn More About Clinical Trials
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Where NCT03299049's enrollment target sits among peer trials
1,049 27th of 542 higher than 516 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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