NCT06101342

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

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre-Exposure Prophylaxis of HIV Infection

Interventions

Type	Name	Description
DRUG	Lenacapavir Injection	Administered subcutaneously
DRUG	Lenacapavir Tablet	Administered orally
DRUG	Emtricitabine/tenofovir disoproxil fumarate (F/TDF)	Administered orally

Timeline

• Start date: 2023-12-13
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-10-26
• Last updated: 2026-03-02

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study