Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

NCT07047716 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GS-US-712-7286
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 31

Brief Summary

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.

Conditions

HIV Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (4)

• Plasma LEN Ctrough at Week 52

  Ctrough is defined as the concentration at the end of the dosing interval.

  Week 52

• Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)

  First dose up to 30 days post last dose (approximately 3 years)

• Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities

  First dose up to 30 days post last dose (up approximately 3 years)

• Percentage of Participants With Discontinuation due to Adverse Event

  First dose up to 30 days post last dose (approximately 3 years)

Study Arms (2)

Lenacapavir (LEN)

EXPERIMENTAL

Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks: * LEN 3000 mg injection once on Day 1 * Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period Participant will receive additional oral LEN if IM injection are not available. If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks.

Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet

LEN Extension Phase

EXPERIMENTAL

Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase. Participants will receive oral LEN if IM injections are not available. If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks.

Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet

Interventions

Lenacapavir Injection DRUG

Administered intramuscularly

LEN Extension Phase; Lenacapavir (LEN)

Lenacapavir Tablet DRUG

Administered orally

LEN Extension Phase; Lenacapavir (LEN)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Cisgender men, Transgender women, Transgender men, Cisgender women, and Gender non-binary
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 16 years of age at screening.
• Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
• Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
• For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months
• For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
• Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
• Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.

You may not qualify if:

• Current signs or symptoms suggesting HIV infection
• Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
• Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
• Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
• Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (31)

UAB Sexual Health Research Clinic

Birmingham, Alabama, 35233, United States

RECRUITING

UCLA Clinic Care

Los Angeles, California, 90035, United States

RECRUITING

Ruane Clinical Research Group, Inc.

Los Angeles, California, 90036, United States

RECRUITING

UCLA Vine Street Clinic

Los Angeles, California, 90038, United States

RECRUITING

Mills Clinical Research

Los Angeles, California, 90069, United States

RECRUITING

BIOS Clinical Research

Palm Springs, California, 92262, United States

RECRUITING

UCSD AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

RECRUITING

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

Yale University; School of Medicine; AIDS Program

New Haven, Connecticut, 06510, United States

RECRUITING

Whitman-Walker Institute, Inc.

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

RECRUITING

The ID Prevention Research Unit

Miami, Florida, 33136, United States

RECRUITING

University of South Florida - Curran Children's Health Center

Tampa, Florida, 33606, United States

RECRUITING

The Hope Clinic of Emory University

Atlanta, Georgia, 30030, United States

RECRUITING

Ponce de Leon Center Clinical Research Site

Atlanta, Georgia, 30303, United States

NOT YET RECRUITING

University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS)

Chicago, Illinois, 60612, United States

RECRUITING

Howard Brown Health Center

Chicago, Illinois, 60613, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70119, United States

RECRUITING

Johns Hopkins Hospital - Clinical Research Unit

Baltimore, Maryland, 21287, United States

RECRUITING

Fenway Health

Boston, Massachusetts, 02215, United States

RECRUITING

Be Well Medical Center

Berkley, Michigan, 48072, United States

RECRUITING

Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center

New York, New York, 10029, United States

RECRUITING

ICAP at Columbia University- Bronx Prevention Center

The Bronx, New York, 10451, United States

RECRUITING

NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Penn Prevention Unit

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Central Texas Clinical Research

Austin, Texas, 78705, United States

RECRUITING

The Crofoot Research Center

Houston, Texas, 77098, United States

RECRUITING

Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: It is a single arm study that means all participants will receive LEN. However, the study provides LEN in 2 phases, therefore, the two phases are reported as 2 separate arms.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)