Build status - In Progress
Evaluating the Efficacy and Safety of Long-Acting Lenacapavir for HIV PrEP
Recruiting
16 years - 100 years
Male
Phase
3
40 participants needed
1 Location
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy Volunteers,HIV/AIDS,PrEP,Lenacapavir,Injectable PrEP
-
Age: 16 years - 100 years
-
Gender: Male
Updated on
04 Aug 2024.
Study ID: 849273
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