Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

Phase 2 Active not recruiting 181 enrolled Gilead Sciences HIV Prevention Trials Network · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab National Institute on Drug Abuse (NIDA) · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). The primary objectives of this study are to characterize the pharmacokinetics (PK) of LEN and to evaluate the safety of LEN and F/TDF for PrEP in US PWID.

Timeline

Start: 2023-12-13
Primary completion: 2028-01
Completion: 2028-01

Publications

Martinez S, Garcia-Romeu A, Wisdom J, Jones J. Methamphetamine use and HIV prevention: a qualitative study on challenges and opportunities for PrEP utilization. AIDS Care. 2026 Apr;38(4):856-869. doi: 10.1080/09540121.2025.2611079. Epub 2026 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenacapavir	Small molecule	600 mg	Subcutaneous
Subject	Lenacapavir	Small molecule	927 mg	Subcutaneous
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral

Indications

No indication recorded.