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NCT06104306 · ClinicalTrials.gov registry record · Phase 4
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
A Phase 4 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
- 18
- Study locations
NCT06104306: Completed Phase 4 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT06104306 is a Phase 4 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 33 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (91% lower). The trial reports 18 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06104306, a Phase 4 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale. The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines
Conditions Studied
Interventions
- DRUG B/F/TAF
Study Locations (18)
Other
- Hamilton Health Sciences-SIS Clinic - Hamilton
- St. Michael's Hospital - Toronto
- University Health Network - Toronto General Hospital - Toronto
- CHU Bordeaux - Hopital Saint-Andre - Bordeaux
- APHM - Hospital Sainte Marguerite - Marseille
- CHR Orleans - Orléans
- Centre Hospitalier Annecy Genevois - Pringy
- HU de Strasbourg - Nouvel Hopital Civil - Strasbourg
California
- Franco Felizarta, MD - Bakersfield
- BIOS Clinical Research - Palm Springs
- UC San Diego AntiViral Research Center (AVRC) - San Diego
Florida
- Midway Immunology and Research Center - Ft. Pierce
- Bliss Health - Orlando
Indiana
- Indiana University Infectious Diseases Research - Indianapolis
Massachusetts
- Boston Medical Center - Boston
Nevada
- Las Vegas Research Center - Las Vegas
New Jersey
- Saint Michael's Medical Center - Newark
Washington
- MultiCare Rockwood Main Clinic - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2025-04-23 |
| Phase | Phase 4 |
What the finished NCT06104306 record still lists
NCT06104306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (91% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which B/F/TAF is the first listed.
NCT06104306 lists 18 locations in 8 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06104306 about?
NCT06104306 is a clinical study titled "Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)". 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 wi...
What is the current status of trial NCT06104306?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2023-12-13. Estimated completion is 2025-04-23.
What conditions does trial NCT06104306 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06104306?
The interventions under investigation include: B/F/TAF (DRUG).
Who is sponsoring clinical trial NCT06104306?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06104306 being conducted?
This trial has 18 study locations across California, Florida, Indiana, Massachusetts, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06104306's enrollment target sits among peer trials
33 55th of 71 higher than 16 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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