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

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)

This project will see if using lenacapavir (YEZTUGO) as a PrEP option helps people at risk for HIV stay on prevention over one year in U.S. clinics.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Locations: 10 sites (Beverly Hills, California and 9 other locations)
• Trial ID: NCT07473778 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults who are HIV-1 negative, present at a participating clinic wanting or needing PrEP, and are eligible for lenacapavir under local clinical procedures — including new users and those switching from oral or injectable PrEP.

Not a fit: People living with HIV, those with contraindications to lenacapavir, or those unable to attend follow-up visits or access the participating clinics are unlikely to benefit.

Why it matters

Potential benefit: If successful, results could show that lenacapavir provides a convenient long-acting PrEP option that helps more people stay protected against HIV.

How similar studies have performed: Long-acting injectable PrEP with cabotegravir has shown strong efficacy in clinical trials, but lenacapavir’s use for PrEP is newer and real-world evidence remains limited.

Eligibility criteria

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 this trial is running

Beverly Hills, California and 9 other locations

• Pacific Oaks Medical Group — Beverly Hills, California, United States (Recruiting)
• Mills Clinical Research — West Hollywood, California, United States (Recruiting)
• Bliss Health — Orlando, Florida, United States (Recruiting)
• Pineapple Healthcare Orlando — Orlando, Florida, United States (Recruiting)
• AHF - Pensacola — Pensacola, Florida, United States (Recruiting)
• Faebris Medical & Community Education — Atlanta, Georgia, United States (Recruiting)
• Chase Brexton Health Care — Baltimore, Maryland, United States (Recruiting)
• Be Well Medical Center — Berkley, Michigan, United States (Recruiting)
• The Aliveness Project — Minneapolis, Minnesota, United States (Recruiting)
• KC Care Health Center — Kansas City, Missouri, United States (Recruiting)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions HIV Infections