Overview

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

Status:
Recruiting

Trial end date:
2028-01-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Gilead Sciences

Collaborator:

HIV Prevention Trials Network

Treatments:

Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir