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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.) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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.)

A Phase 4, Open-label, Single Arm Study to Optimize Implementation of CABENUVA for the Treatment of HIV-1, for Administration in U.S. Community-based Infusion Centers or Other Alternate Sites of Administration

NCT04982445•ViiV Healthcare

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (15)

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

Key Dates

Start Date

November 18, 2021

Primary Completion Date

January 31, 2024

Completion Date

January 31, 2024

Last Updated

April 1, 2025

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

CABENUVA

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.)

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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