NCT06333808

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Bictegravir	Tablets administered orally without regard to food
DRUG	Lenacapavir	Tablets administered orally without regard to food
DRUG	B/F/TAF	Tablets administered orally without regard to food
DRUG	Placebo to match B/F/TAF	Tablets administered orally without regard to food
DRUG	Placebo to match BIC/LEN	Tablets administered orally without regard to food

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-10-27
• Completion: 2029-12-01
• First posted: 2024-03-27
• Last updated: 2025-11-05

Locations

104 sites across 14 countries: United States, Argentina, Australia, Canada, Dominican Republic, Germany, Italy, Japan, Mexico, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study