PURPOSE 2

Gilead's lenacapavir trials are resumed as of May 2022. See Gilead’s press release on the release of FDA's clinical hold.

Trial was on clinical hold due to concerns about compatibility of the glass vials with the lenacapavir solution. See Gilead’s press release on the clinical hold in December 2021.

The primary objective of this study is to evaluate the efficacy of lenacapavir (LEN) in preventing the risk of human immunodeficiency virus (HIV) infection relative to the background HIV 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 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 Coverage Phase.

The primary objective for the Incidence Phase of this study is to estimate the HIV background incidence rate. The primary objective of the Randomized Phase of this study is to evaluate the efficacy of lenacapavir for HIV 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 infection.

Last updated May 17, 2022