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.)

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT04982445

Run by

ViiV Healthcare

People needed

44

Starts

2021-11-18

Expected to finish

2024-01-31

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Evans, Georgia, United States
• GSK Investigational Site — East Lansing, Michigan, United States
• GSK Investigational Site — Novi, Michigan, United States
• GSK Investigational Site — Plymouth, Minnesota, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Florence, South Carolina, United States
• GSK Investigational Site — Summerville, South Carolina, United States
• GSK Investigational Site — West Columbia, South Carolina, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — Kingwood, Texas, United States
• GSK Investigational Site — North Richland Hills, Texas, United States
• GSK Investigational Site — Plano, Texas, United States

Full record on ClinicalTrials.gov

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