Evaluating the Efficacy and Safety of Long-Acting Lenacapavir for HIV PrEP
Study Overview
The
primary objective of the PURPOSE2 study is to evaluate the efficacy of
lenacapavir (LEN) in preventing the risk of contracting human immunodeficiency virus
(HIV).
The study will be
conducted in 2 parts: a cross-sectional study (Incidence Phase) and a
double-blind, randomized study (Randomized Phase).
1) The Incidence Phase
will include testing for HIV, which will provide us with an estimate of the
HIV-1 incidence rate. Only those who participate and are found eligible in the Incidence Phase will be invited to participate in the Randomized Phase.
2) The Randomized Phase looks 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. Only those who have successfully completed the Incidence Phase portion will be invited to screen for the Randomized Phase.
- Study Identifier: 849273
Recruitment Status
OpenContact the research team to learn more about this study.
Fields marked with asterisk (*) are required
