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.)

NCT04982445 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 214747
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

HIV Infections

Keywords

HIV; CABENUVA; Intramuscular; Cabotegravir; Rilpivirine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM)

  Feasibility of Intervention Measure (FIM) were employed to evaluate the feasibility of CABENUVA administration at Infusion Centers (IC)/ alternate sites of administration (ASA). Higher scores on FIM indicate greater feasibility, where each item can be scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5). This scoring looked at the number responding '4' or '5' to each question divided by the number completing all 4-items where "items" refer to the individual questions or statements that participants respond to in order to assess their perceptions of an intervention. Each item is designed to measure a specific aspect of either acceptability or feasibility.

  At Month 8

Secondary Outcomes (101)

• Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1 and 3

  At Months 1 and 3

• Number of HIV Care Providers Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1, 4 and 8

  At Months 1, 4, and 8

• Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Prior to Month 1 and at Months 3 and 8

  Prior to Month 1 (Baseline) and at Months 3 and 8

• Change in FIM Score Over Time in Participants at Month 3 and 8

  From Month 1 (Baseline) to Months 3 and 8

• Change in FIM Score Over Time in HIV Care Providers at Month 4 and 8

  From Month 1 (Baseline) to Months 4 and 8

Study Arms (1)

Participants receiving CABENUVA

EXPERIMENTAL

Eligible participants received CABENUVA injections intramuscularly at infusion centers/ASAs monthly or every-2-months.

Drug: CABENUVA

Interventions

CABENUVA DRUG

CABENUVA will be administered IM at infusion centers/ASAs

Participants receiving CABENUVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (15)

GSK Investigational Site

Evans, Georgia, 30809, United States

Location

GSK Investigational Site

East Lansing, Michigan, 48823, United States

Location

GSK Investigational Site

Novi, Michigan, 48377-2977, United States

Location

GSK Investigational Site

Plymouth, Minnesota, 55446, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28226, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27405, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29414, United States

Location

GSK Investigational Site

Florence, South Carolina, 29501, United States

Location

GSK Investigational Site

Summerville, South Carolina, 29483, United States

Location

GSK Investigational Site

West Columbia, South Carolina, 29169, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76244-5307, United States

Location

GSK Investigational Site

Kingwood, Texas, 77339, United States

Location

GSK Investigational Site

North Richland Hills, Texas, 76180-7379, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

cabotegravir, rilpivirine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: November 18, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (15)