NCT06101329

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pre-Exposure Prophylaxis of HIV Infection

Interventions

Type	Name	Description
DRUG	Lenacapavir Tablet	Tablets administered orally without regard of food
DRUG	Lenacapavir Injection	Injection administered subcutaneously
DRUG	Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)	200/300mg fixed dose combination (FDC) tablets administered orally

Timeline

• Start date: 2023-11-17
• Primary completion: 2026-07-01
• Completion: 2028-01-01
• First posted: 2023-10-26
• Last updated: 2025-09-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study