Clinical Trial

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

Study acronym: PURPOSE 4
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Primary completion moved earlier: 2028-01 -> 2026-07-27 2026-08-14
Trial Details
NCT Number NCT06101342
Lead Sponsor Gilead Sciences
Collaborators: HIV Prevention Trials Network, National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Pre-Exposure Prophylaxis of HIV Infection
Enrollment 181 participants
Start Date 2023-12-13
Primary Completion 2026-07-27 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13