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.) (GLACIER)

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: CABENUVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982445

214747

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Participants receiving CABENUVA

Experimental group

Description:

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

Treatment:

Drug: CABENUVA