Lenacapavir (YEZTUGO) as an HIV PrEP option in routine clinical care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, real-world project follows people at U.S. clinical sites who start, switch to, or consider lenacapavir (YEZTUGO) as HIV PrEP and records how it is initiated, used, and stopped in routine practice. It includes new PrEP users and current or former users of oral PrEP (F/TDF or F/TAF) and injectable PrEP (cabotegravir), and collects data on persistence on LEN PrEP through Week 52. Participants are enrolled under standard-of-care procedures with informed consent and require HIV-1 negative status at screening. Data from participating clinics in the United States will be pooled by the sponsor to characterize real-life patterns of LEN PrEP use.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;
* Willing and able to comply with all study requirements;
* Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;
* Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;
* After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:

  1. Selects LEN PrEP as their chosen PrEP method; OR,
  2. Selects a different PrEP method or chooses not to start or continue PrEP.

Key Exclusion Criteria:

* Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• UAB 1917 Research Clinic
  Birmingham, Alabama, United States Recruiting
• Pacific Oaks Medical Group
  Beverly Hills, California, United States Recruiting
• Ruane Clinical Research Group Inc.
  Los Angeles, California, United States Recruiting
• Sutter Health- East Bay Advanced Care
  Oakland, California, United States Recruiting
• Family Health Centers of San Diego
  San Diego, California, United States Recruiting
• UC San Diego (UCSD) AntiViral Research Center (AVRC)
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Camino HIV Prevention and Care Study

  This study tests a combined legal and peer-support program to help Latin American adults in DC and the Bay Area improve HIV testing, PrEP use, and care engagement.

  Recruiting American University · Berkeley, California and 1 other locations · NCT07834853

• VH4367310 in healthy adults: testing single increasing doses for safety and how it behaves in the body

  This study tests a single rising dose of VH4367310, a cabotegravir prodrug, to see how it behaves in the body and how safe and tolerable it is in healthy adults aged 18 to 55.

  Recruiting at 2 sites Phase 1 ViiV Healthcare · Glendale, California and 1 other locations · NCT07818915

• Online cohort of sexual and gender minorities testing digital support to boost PrEP and ART use

  In Brazil, sexually and gender diverse adults are being followed online to see if weekly WhatsApp reminders help people stick to PrEP or ART.

  Recruiting Oswaldo Cruz Foundation · Rio de Janeiro, Rio de Janeiro · NCT07772791

• Metabolic Liver Disease in People Newly Diagnosed with HIV

  This study tests whether HIV-infected adults who are starting ART are more likely to develop MASLD and related liver issues than HIV-negative adults over five years.

  Recruiting at 11 sites Guven Health Group · Ankara, Ankara and 10 other locations · NCT07737340

• Screen2Prevent: HIV screening for teens and young adults in emergency departments

  The study tests three ways of offering HIV screening to people aged 14–24 in emergency departments to see if it helps link them to PrEP or HIV treatment using digital health tools.

  Recruiting at 5 sites Westat · Tampa, Florida and 4 other locations · NCT07728123

• Long-acting LEN/TAB/ZAB vs CAB/RPV in adults with HIV-1 who are virologically suppressed on daily ART

  This study tests whether switching to a weekly-plus long-acting injectable regimen of lenacapavir, teropavimab, and zinlirvimab works as well as a two-drug injectable regimen of cabotegravir and rilpivirine for adults with HIV-1 who already have undetectable virus on daily treatment.

  Recruiting at 19 sites Phase 3 Gilead Sciences · San Francisco, California and 18 other locations · NCT07682961

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.