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

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.

Timeline

Start

2024-10-08

Primary completion

2026-04-23

Completion

2030-08

Outcome

Met primary endpoint

release “ISLEND-2試験の結果 48週時において、ISL/LENは、ウイルス学的抑制の維持において毎日経口投与するHIV標準治療に対し非劣性でした。” msd.co.jp ↗

release “primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials” gilead.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Islatravir	Other / unclassified	—	Oral
Subject	Lenacapavir	Small molecule	—	Oral
Comparator	Abacavir	Other / unclassified	—	—
Comparator	Bictegravir	Small molecule	—	—
Comparator	Cobicistat	Small molecule	—	—
Comparator	Darunavir	Small molecule	—	—
Comparator	Dolutegravir	Other / unclassified	—	—
Comparator	Doravirine	Small molecule	—	—
Comparator	Lamivudine	Other / unclassified	—	—
Comparator	Raltegravir	Other / unclassified	—	—
Comparator	Rilpivirine	Small molecule	—	—
Comparator	Tenofovir disoproxil fumarate	Small molecule	—	—
Comparator	elvitegravir	Small molecule	—	—
Comparator	emtricitabine	Other / unclassified	—	—
Comparator	tenofovir alafenamide	Small molecule	—	—

Indications