Lenacapavir for HIV Prevention
(PURPOSE 2 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing lenacapavir, a drug that may help prevent HIV. It targets people who are at risk of getting HIV. The drug works by stopping the virus from making more copies of itself. Lenacapavir was developed by Gilead Sciences Inc. and has been approved for use in combination with other treatments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Lenacapavir for HIV prevention?
Is lenacapavir safe for humans?
What makes the drug Lenacapavir unique for HIV prevention?
Lenacapavir is unique because it is a long-acting injectable drug that targets the HIV-1 capsid (a protein shell of the virus), allowing for dosing every six months, which reduces the need for daily pills. This makes it different from most current HIV treatments that require daily administration.12468
Research Team
Gilead Study Director
Principal Investigator
Gilead Sciences
Eligibility Criteria
This trial is for individuals at risk of HIV infection who have had condomless receptive anal sex with male partners, used stimulants during sex recently, or had certain sexually transmitted infections. They must have a kidney function test result (eGFR) ≥ 60 mL/min and not previously taken long-acting PrEP or oral PrEP in the past 12 weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Blinded Phase
Participants receive either SC lenacapavir or placebo every 26 weeks, with oral F/TDF or PTM LEN for approximately 52 weeks
PK Tail Phase
Participants who discontinue early or choose not to continue in the LEN OLE Phase receive oral F/TDF or F/TAF for 78 weeks
LEN Open-Label Extension (OLE) Phase
Participants continue or switch to SC LEN 927 mg every 26 weeks, with visits every 13 weeks, until LEN is available or study is discontinued
Follow-up
Participants transition to local PrEP services and have a 30-day follow-up visit after study completion or early exit
Treatment Details
Interventions
- F/TAF
- F/TDF
- Lenacapavir
Lenacapavir is already approved in United States for the following indications:
- Treatment of HIV
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Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine