This study is in progress, not accepting new patients

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

a study on HIV/AIDS Immunodeficiency

Summary

Eligibility
for people ages 16 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) - 1 infection relative to the background HIV-1 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-1 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 Phase. The primary objective for the Incidence Phase of this study is to estimate the HIV-1 background incidence rate. The primary objective of the Randomized Blinded Phase of this study is to evaluate the efficacy of lenacapavir for HIV-1 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-1 infection.

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 HIV Infections Acquired Immunodeficiency Syndrome Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination 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

  • 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

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

Locations

  • UCSD Anti Viral Research Center
    San Diego California 92103 United States
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    Los Angeles California 90502 United States

Details

Status
in progress, not 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