NCT06630299

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• 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 safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.

Conditions

• HIV-1-Infection

Interventions

Type	Name	Description
DRUG	ISL/LEN	Tablet administered orally
DRUG	Antiretroviral Combinations	2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-04-01
• Completion: 2030-08-01
• First posted: 2024-10-08
• Last updated: 2025-11-14

Locations

100 sites across 14 countries: United States, Argentina, Australia, Germany, Japan, Netherlands, Poland, Puerto Rico, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study