Study Details

PROTOCOL 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.

Participation Requirements

Age

16 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

HIV Pre-exposure Prophylaxis

Gender

Cisgender men, Transgender women, Transgender men, Cisgender women, and Gender non-binary

Date

July 2025 - September 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Lenacapavir Injection, Lenacapavir Tablet

Eligibility Information

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.

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.

Locations

Locations (3)

Mills Clinical Research

Los Angeles, California, United States, 90069

Midway Immunology and Research Center

Ft. Pierce, Florida, United States, 34982

The Crofoot Research Center

Houston, Texas, United States, 77098

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

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