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NCT02951052 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.

Active
Registry status
Phase 3
Development phase
618
Enrollment target
20
Study locations

NCT02951052 is a Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 618 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT02951052, a Phase 3 study of HIV Infections and Infection, Human Immunodeficiency Virus, is active but no longer recruiting, sponsored by ViiV Healthcare.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
618 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

HIV Infections Infection, Human Immunodeficiency Virus

Interventions

  • DRUG Cabotegravir (CAB) tablet
  • DRUG Rilpivirine (RPV) tablet
  • DRUG Cabotegravir - Injectable Suspension (CAB LA)
  • DRUG Rilpivirine - Injectable Suspension (RPV LA)
  • DRUG 2 NRTIs plus an INI, NNRTI, or PI

Study Locations (20)

California

  • GSK Investigational Site - Bakersfield
  • GSK Investigational Site - Long Beach
  • 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

Florida

  • GSK Investigational Site - Fort Lauderdale
  • GSK Investigational Site - Ft. Pierce
  • GSK Investigational Site - Sarasota
  • GSK Investigational Site - Vero Beach

District of Columbia

  • GSK Investigational Site - Washington D.C.
  • GSK Investigational Site - Washington D.C.
  • GSK Investigational Site - Washington D.C.

Alabama

  • GSK Investigational Site - Birmingham

Arizona

  • GSK Investigational Site - Phoenix

Colorado

  • GSK Investigational Site - Denver

Georgia

  • GSK Investigational Site - Macon

Illinois

  • GSK Investigational Site - Chicago

Trial Details

FieldValue
Enrollment Target 618 participants
Start Date 2016-10-28
Est. Completion 2029-12-31
Phase Phase 3

Sponsor

ViiV Healthcare

182 total trials

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What the Registry Record Tells You About NCT02951052

The ClinicalTrials.gov registry entry for NCT02951052 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 618 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (39% higher). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cabotegravir (CAB) tablet is the first listed.

NCT02951052 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT02951052 about?

NCT02951052 is a clinical study titled "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". 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...

What is the current status of trial NCT02951052?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2016-10-28. Estimated completion is 2029-12-31.

What conditions does trial NCT02951052 study?

This clinical trial studies the following conditions: HIV Infections, Infection, Human Immunodeficiency Virus.

What interventions are being tested in trial NCT02951052?

The interventions under investigation include: Cabotegravir (CAB) tablet (DRUG), Rilpivirine (RPV) tablet (DRUG), Cabotegravir - Injectable Suspension (CAB LA) (DRUG), Rilpivirine - Injectable Suspension (RPV LA) (DRUG), 2 NRTIs plus an INI, NNRTI, or PI (DRUG).

Who is sponsoring clinical trial NCT02951052?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02951052 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.