Recruiting

Baptist Health Lexington

David Frederick Dougherty

Principal Investigator

Janie Platt

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HIV PREP: Phase 3, double-blind, multicenter, randomized study to evaluate efficacy and safety of subcut twice yearly long-acting Lenacapavir for HIV Pre-Exposure prophylaxis in Cisgender Men, Transgender Women, Transgender Men and Gender Nonbinary People ≥ 16 who have sex with male partners and are at risk for HIV infection.
Description
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.
Eligibility Criteria

Inclusion:

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.