NCT06104306

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

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	Tablets administered orally without regard to food

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-01-29
• Completion: 2025-04-23
• First posted: 2023-10-27
• Last updated: 2026-02-11
• Results posted: 2026-02-11

Locations

18 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated drug study