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

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a study on HIV/AIDS PrEP Immunodeficiency Transgender Health

Summary

Eligibility
for people ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA UCSD
Dates
study start
estimated completion

Description

Summary

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

Keywords

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)

Eligibility

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.

Locations

  • UCLA CBAM Vine Street Clinic accepting new patients
    Los Angeles California 90038 United States
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Los Angeles California 90502 United States
  • UCSD Anti Viral Research Center accepting new patients
    San Diego California 92103 United States
  • Kaiser Permanente accepting new patients
    San Francisco California 94118 United States
  • Bridge HIV at the San Francisco Department of Public Health accepting new patients
    San Francisco California 94102 United States
  • Optimus Medical Group accepting new patients
    San Francisco California 94102 United States
  • San Francisco AIDS Foundation withdrawn
    San Francisco California 94103 United States
  • Mills Clinical Research accepting new patients
    Los Angeles California 90069 United States
  • Ruane Clinical Research Group Inc. accepting new patients
    Los Angeles California 90036 United States
  • Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC) accepting new patients
    Los Angeles California 90059 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT04925752
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 3000 study participants
Last Updated