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

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: HIV Pre-exposure Prophylaxis

Treatments: Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07047716

GS-US-712-7286

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Lenacapavir (LEN)

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir Injection

Drug: Lenacapavir Tablet

LEN Extension Phase

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir Injection

Drug: Lenacapavir Tablet