Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1)

  • End date
    Jul 21, 2027
  • participants needed
  • sponsor
    Gilead Sciences
Updated on 21 August 2023
Accepts healthy volunteers


The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.

Condition Pre-Exposure Prophylaxis of HIV Infection
Treatment F/TAF, F/TDF, Oral Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, Subcutaneous (SC) Lenacapavir (LEN), PTM F/TAF
Clinical Study IdentifierNCT04994509
SponsorGilead Sciences
Last Modified on21 August 2023


Yes No Not Sure

Inclusion Criteria

Incidence Phase
HIV-1 status unknown at initial screening and no prior human immunodeficiency virus ( HIV)-1 testing within the last 3 months
Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM)
Randomized Phase
Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing
Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening
Body weight ≥ 35 kg

Exclusion Criteria

Prior receipt of an HIV vaccine
Prior use of long-acting systemic pre-exposure prophylaxis (PrEP)
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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