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

NCT06101329 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2025-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • HIV Prevention Trials Network

    collaborator NETWORK

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2026-07-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101329 on ClinicalTrials.gov