Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) in the United States (U.S.)

• Status: Not yet recruiting
• Trial end date: 2023-02-17
• Target enrollment: 0
• Participant gender: All

Summary

GLACIER (Giving Long Acting CABENUVA in an Infusion centER) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers in South-eastern United States. In this study, the intervention is the process of using an infusion center as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC staff. In this study, Month 1 is the Baseline visit.

CABENUVA is a registered trademark of ViiV Healthcare.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViiV Healthcare

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 on oral VOCABRIA + EDURANT for approximately 1 month (at least 28 days) or already taking CABENUVA prior to Baseline/Month 1 and the last dose was within a 1 month plus minus (+-) 7-day window.

• Capable of giving signed informed consent.

• Agreement to receive CABENUVA IM injections at participating infusion center.

Exclusion Criteria:

• Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA United States Prescribing information [USPI], 2021) in consultation with the HIV care provider.