Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
Running, not enrolling · Phase 2
Conditions studied: Pre-Exposure Prophylaxis of HIV Infection
In brief
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.
Key facts
- Study ID
- NCT06101342
- Run by
- Gilead Sciences
- People needed
- 181
- Starts
- 2023-12-13
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- UCLA Vine Street Clinic — Los Angeles, California, United States
- UCSD AntiViral Research Center (AVRC) — San Diego, California, United States
- University of Miami - Converge Miami Building — Miami, Florida, United States
- Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research — Baltimore, Maryland, United States
- Rutgers New Jersey Medical School, Department of Medicine — Newark, New Jersey, United States
- ICAP at Columbia University- Bronx Prevention Center — The Bronx, New York, United States
- University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit — Philadelphia, Pennsylvania, United States
- Houston AIDS Research Team CRS — Houston, Texas, United States
- West Virginia University — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
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