Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

Last updated: March 18, 2025
Sponsor: ViiV Healthcare
Overall Status: Completed

Phase

4

Condition

Hiv Infections

Treatment

CABENUVA

Clinical Study ID

NCT04982445
214747
  • Ages > 18
  • All Genders

Study Summary

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Adults (greater than or equal to [>=]18 years old) at the time of signing the informed consent.

  • HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI).

  • Participants can be enrolled

  • If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or

  • Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or

  • Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infusion Center/ASA on the last day of any other antiretroviral therapy

  • Agreement to receive CABENUVA IM injections at participating infusion center/ASA.

Exclusion criteria

  • Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA [USPI]) in consultation with the HIV care provider.

  • Contraindications, as per the current Prescribing Information [CABENUVA USPI]

  • New health condition / prohibited medication reported - Other Reason at the discretion of the HIV care provider or IC/ ASA staff

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: CABENUVA
Phase: 4
Study Start date:
November 18, 2021
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • GSK Investigational Site

    Los Angeles, California 90001
    United States

    Site Not Available

  • GSK Investigational Site

    Evans, Georgia 30809
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • GSK Investigational Site

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • GSK Investigational Site

    Grand Rapids, Michigan 49525
    United States

    Site Not Available

  • GSK Investigational Site

    Novi, Michigan 48377-2977
    United States

    Site Not Available

  • GSK Investigational Site

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • GSK Investigational Site

    Lee's Summit, Missouri 64063-1052
    United States

    Site Not Available

  • GSK Investigational Site

    Arden, North Carolina 28704
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28226
    United States

    Site Not Available

  • GSK Investigational Site

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • GSK Investigational Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • GSK Investigational Site

    Supply, North Carolina 29462
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Aiken, South Carolina 29801
    United States

    Site Not Available

  • GSK Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • GSK Investigational Site

    Beaufort, South Carolina 29906
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • GSK Investigational Site

    Florence, South Carolina 29501
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • GSK Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • GSK Investigational Site

    Myrtle Beach, South Carolina 28579
    United States

    Site Not Available

  • GSK Investigational Site

    Okatie, South Carolina 29909
    United States

    Site Not Available

  • GSK Investigational Site

    Pawleys Island, South Carolina 29585
    United States

    Site Not Available

  • GSK Investigational Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • GSK Investigational Site

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • GSK Investigational Site

    Summerville, South Carolina 29483
    United States

    Site Not Available

  • GSK Investigational Site

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76244-5307
    United States

    Site Not Available

  • GSK Investigational Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • GSK Investigational Site

    North Richland Hills, Texas 76180-7379
    United States

    Site Not Available

  • GSK Investigational Site

    Pasadena, Texas 77505-3959
    United States

    Site Not Available

  • GSK Investigational Site

    Plano, Texas 75093
    United States

    Site Not Available

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