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ACTIVE NOT RECRUITING 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

NCT03299049 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,049 participants
Start Date 2017-10-27
Est. Completion 2029-12-31
Phase Phase 3

Sponsor

ViiV Healthcare

82 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03299049

The ClinicalTrials.gov registry entry for NCT03299049 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 1,049 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions — of which Cabotegravir Tablets 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: NCT03299049 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, District of Columbia, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03299049?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial