Evaluating the Efficacy and Safety of Long-Acting Lenacapavir for HIV PrEP

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: Between 16 Years - 100 Years
  • Gender: Male


Updated on 30 Nov 2023. Study ID: 849273

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

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