Recruiting

LenacapavirImplementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

Sponsor:

Gilead Sciences

Code:

NCT07473778

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lenacapavir Injection

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Emtricitabine/tenofovir alafenamide (F/TAF)

Cabotegravir (CAB)

Lenacapavir Tablet

Study Details

Brief summary:

The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.

The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Conditions

HIV Infections

Study ID

NCT07473778

Start date

Mar 17, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;
Willing and able to comply with all study requirements;
Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;
Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;
After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:

1. Selects LEN PrEP as their chosen PrEP method; OR,
2. Selects a different PrEP method or chooses not to start or continue PrEP.

Key Exclusion Criteria:

Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

LEN PrEP

Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period

Other PrEP

Participants in diverse clinical settings in the United States (US) who choose other PrEP options ( F/TDF, F/TAF, CAB) or No PrEP.

Interventions

Lenacapavir Injection

Administered via subcutaneous (SC) injection

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Tablets administered orally

Emtricitabine/tenofovir alafenamide (F/TAF)

Tablets administered orally

Cabotegravir (CAB)

Administered via intramuscular (IM) injection

Lenacapavir Tablet

Administered orally

Primary outcome measure

Proportion of Participants with LEN PrEP Persistence at Week 52 [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

UAB 1917 Research Clinic

Recruiting

Birmingham, Alabama, United States, 35222

Pacific Oaks Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Ruane Clinical Research Group Inc.

Recruiting

Los Angeles, California, United States, 90036

Family Health Centers of San Diego

Recruiting

San Diego, California, United States, 92102

UC San Diego (UCSD) AntiViral Research Center (AVRC)

Recruiting

San Diego, California, United States, 92103

Mills Clinical Research

Recruiting

West Hollywood, California, United States, 90046

Vivent Health

Recruiting

Denver, Colorado, United States, 80246

Bliss Health

Recruiting

Orlando, Florida, United States, 32803

Pineapple Healthcare Orlando

Recruiting

Orlando, Florida, United States, 32829

AHF - Pensacola

Recruiting

Pensacola, Florida, United States, 32503

Faebris Medical & Community Education

Recruiting

Atlanta, Georgia, United States, 01111

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

DOM/Project WISH Research Clinic

Recruiting

Chicago, Illinois, United States, 60612

Rush University Medical Center/Division of Infectious Diseases

Recruiting

Chicago, Illinois, United States, 60612

Howard Brown Health

Recruiting

Chicago, Illinois, United States, 60613

The Clinic NOLA

Recruiting

New Orleans, Louisiana, United States, 70115

Chase Brexton Health Care

Recruiting

Baltimore, Maryland, United States, 21201

Fenway Health

Recruiting

Boston, Massachusetts, United States, 02215

Be Well Medical Center

Recruiting

Berkley, Michigan, United States, 48072

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

The Aliveness Project

Recruiting

Minneapolis, Minnesota, United States, 55409

KC Care Health Center

Recruiting

Kansas City, Missouri, United States, 64111

Washington University School of Medicine Infectious Disease Clinical Research Unit

Recruiting

St Louis, Missouri, United States, 63110

University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center

Recruiting

Omaha, Nebraska, United States, 68198

NYC Health + Hospitals / Bellevue

Recruiting

New York, New York, United States, 10016

Colombia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

University of Cincinnati College of Medicine

Recruiting

Cincinnati, Ohio, United States, 45267

Ohio State University Infectious Diseases Clinical Trials Unit

Recruiting

Columbus, Ohio, United States, 43210

Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Abounding Prosperity Inc.

Recruiting

Dallas, Texas, United States, 75215

Prism Health

Recruiting

Dallas, Texas, United States, 75246

UT Health

Recruiting

Houston, Texas, United States, 77009

Thomas Street at Quentin Mease Health Center

Recruiting

Houston, Texas, United States, 77030

West Virginia Health Right, Inc.

Recruiting

Charleston, West Virginia, United States, 25302

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-19.