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

Not Applicable

Recruiting

• Conditions: HIV Pre-exposure Prophylaxis
• Interventions: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet

• Registration Number: NCT07047716
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Study First Posted: 2025-07-02
• Study Start: 2025-07-25
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-11
• Primary Completion: 2028-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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:

  1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
  2. 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
  3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
  4. 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.

Key

Exclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenacapavir (LEN)	Lenacapavir Injection	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.
LEN Extension Phase	Lenacapavir Injection	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.
Lenacapavir (LEN)	Lenacapavir Tablet	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.
LEN Extension Phase	Lenacapavir Tablet	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.

Primary Outcome Measures

Name	Time	Method
Plasma LEN Ctrough at Week 52	Week 52	Ctrough is defined as the concentration at the end of the dosing interval.
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 Experiencing Treatment-emergent Adverse Event (TEAEs)	First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event	First dose up to 30 days post last dose (approximately 3 years)

Trial Locations

Locations (8)

Ruane Clinical Research Group, Inc.; 🇺🇸 Los Angeles, California, United States

Howard Brown Health Center; 🇺🇸 Chicago, Illinois, United States

Be Well Medical Center; 🇺🇸 Berkley, Michigan, United States

Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States

Mills Clinical Research; 🇺🇸 Los Angeles, California, United States

Midway Immunology and Research Center; 🇺🇸 Ft. Pierce, Florida, United States

The Crofoot Research Center; 🇺🇸 Houston, Texas, United States