Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis

• Status: Recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) infection relative to the background HIV incidence rate.

The study will be conducted in 2 parts: a cross-sectional study (Incidence Phase) and a double-blind, randomized study (Randomized Phase). The Incidence Phase will include initial assessments that will provide an estimate of the concurrent background HIV incidence rate. The Randomized Phase of the study will have a Blinded Phase, a LEN Open-label Extension (OLE) Phase, and a pharmacokinetic (PK) Tail Coverage Phase.

The primary objective for the Incidence Phase of this study is to estimate the HIV background incidence rate. The primary objective of the Randomized Phase of this study is to evaluate the efficacy of lenacapavir for HIV pre-exposure prophylaxis (PrEP) in cisgender men (CGM), transgender women (TGW), transgender men (TGM), and gender nonbinary people (GNB) ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Key Inclusion Criteria:

Incidence Phase

• CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.

• HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months

• Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:

• Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks

• Documented history of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks

• Self-reported use of stimulants with sex in the last 12 weeks

Randomized Phase

• Negative local rapid fourth generation HIV-1 Ab/Ag test confirmed with central HIV-1 testing

• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr)

Key Exclusion Criteria:

Incidence Phase

• Prior use of long-acting systemic PrEP (including cabotegravir or islatravir trials)

• Prior recipient of an HIV vaccine

Randomized Phase

• Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection

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