Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Phase 2 Active not recruiting 142 enrolled Gilead Sciences Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Timeline

Start: 2021-10-05
Primary completion: 2023-12-19
Completion: 2028-03

Publications

Colson AE, Crofoot GE, Ruane PJ, Ramgopal MN, Dretler AW, Nahass RG, Sinclair GI, Berhe M, Roberts A, Applin S, Brinson C, Jayaweera D, Workowski KA, Shihadeh F, Liu SY, Klopfer S, Llamoso C, Madera S, Dvory-Sobol H, Rhee MS, Rhee EG, Baeten JM, Eron JJ. Once-Weekly Oral Islatravir Plus Lenacapavir Versus Daily Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Persons With HIV-1 : A Phase 2 Randomized Study. Ann Intern Med. 2026 Feb;179(2):168-176. doi: 10.7326/ANNALS-25-01939. Epub 2025 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ISL/LEN FDC	Unknown	—	Oral
Subject	Islatravir	Other / unclassified	2 mg	Oral
Subject	Islatravir	Other / unclassified	20 mg	Oral
Subject	Lenacapavir	Small molecule	300 mg	Oral
Subject	bictegravir	Small molecule	50 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral
Subject	tenofovir alafenamide	Small molecule	25 mg	Oral

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Summary

Timeline

Publications

Drugs

Indications