NCT04982445CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 26 Jul 2021
- Start date
- 18 Nov 2021
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT04982445
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 44
- From 18 Nov 2021 to the primary completion date, 31 Jan 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA \[USPI\]) in consultation with the HIV care provider.
- New health condition / prohibited medication reported - Other Reason at the discretion of the HIV care provider or IC/ ASA staff
Other
- Contraindications, as per the current Prescribing Information \[CABENUVA USPI\]
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Feasibility, Fidelity, and Effectiveness of Administering Long-Acting Cabotegravir + Rilpivirine in Infusion Centers in the United States: Findings From the Phase 4 GLACIER Implementation Study.J Int Assoc Provid AIDS Care · 2026 · PMID 42117620
This page is information, not medical advice. Discuss any trial with your doctor.