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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
16 Years
Maximum Age
N/A

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
    • 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)

Key Exclusion Criteria:

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.

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Study Stats
Protocol No.
21-001200
Category
Infectious Disease
Contact
Sandra Macnicoll
Location
  • UCLA Hollywood
For Providers
NCT No.
NCT04925752
For detailed technical eligibility, visit ClinicalTrials.gov.