Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Summary

The goal of this clinical study is to learn how safe it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

Timeline

Start

2023-12-13

Primary completion

2025-01-29

Completion

2025-04-23

Publications

• Background Priyanka Arora, Moti Ramgopal, Thomas CS Martin, Hui Liu, Jason T Hindman, Jason Okulicz, Dhananjay D Marathe, Samir Gupta Pharmacokinetics and Safety Data After Switching From Injectable CAB + RPV to Oral B/F/TAF 20th European AIDS Conference (EACS); October 15-18, 2025
• Background Samir Gupta, Thomas Martin, Cyril Gaultier, Alexandra Kissling, Kathleen Beusterien, Megan Chen, Megan Dunbar, Hui Liu, Brenda Ng, Moti Ramgopal Evaluation of Treatment Satisfaction and Experiences Among People With HIV When Switching to B/F/TAF From CAB + RPV: Results From the Phase 4 EMPOWER Study IDWeek; October 19-22, 2025; Atlanta, GA, USA
• Background Sharon Walmsley, Moti Ramgopal, Thomas Martin, Jason T Hindman, Hui Liu, Keith Aizen, Jason Okulicz, Samir Gupta A Phase 4 Study to Evaluate the Safety and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV IDWeek; October 19-22, 2025; Atlanta, GA, USA

Drugs

Indications