NCT06630286

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	ISL/LEN	Tablet administered orally
DRUG	B/F/TAF	Tablet administered orally
DRUG	PTM B/F/TAF	Tablet administered orally
DRUG	PTM ISL/LEN	Tablet administered orally

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-04-01
• Completion: 2030-08-01
• First posted: 2024-10-08
• Last updated: 2025-11-13

Locations

106 sites across 12 countries: United States, Argentina, Australia, Canada, France, Germany, Japan, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study