Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
Running, not enrolling · Phase 2
Conditions studied: Pre-Exposure Prophylaxis of HIV Infection
In brief
The goal of this clinical study is 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 prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
Key facts
- Study ID
- NCT06101329
- Run by
- Gilead Sciences
- People needed
- 253
- Starts
- 2023-11-17
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-09-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
Where it is running
- UAB, 1917 Research Clinic — Birmingham, Alabama, United States
- UCSD Antiviral Research Center (AVRC) — San Diego, California, United States
- George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
- Ponce de Leon Center Clinical Research Site — Atlanta, Georgia, United States
- Fenway Health — Boston, Massachusetts, United States
- Rutgers New Jesey Medical School - Clinical Research Center — Newark, New Jersey, United States
- Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine — New York, New York, United States
- Harlem Prevention Center CRS — New York, New York, United States
- ICAP at Columbia University - Bronx Prevention Center — The Bronx, New York, United States
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Penn Prevention Research Unit — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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