for people ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
at Sacramento, California and other locations
study start
estimated completion



The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.

Official Title

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection


Pre-Exposure Prophylaxis of HIV Infection, Infections, Communicable Diseases, HIV Infections, Acquired Immunodeficiency Syndrome, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine, Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)


You can join if…

Open to people ages 16 years and up

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
    • 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-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT)
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr)

You CAN'T join if...

Incidence Phase

  • Prior use of oral PrEP (including F/TDF or F/TAF) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir)
  • Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation

Randomized Phase

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


  • One Community Health accepting new patients
    Sacramento California 95811 United States
  • Kaiser-Permanente Medical Center accepting new patients
    Sacramento California 95825 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website Sign up for this study
Phase 3 research study
Study Type
Expecting 3000 study participants
Last Updated