NCT07473778 Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
| NCT ID | NCT07473778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gilead Sciences |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2026-03-17 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.
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.
Contact & Investigator
Gilead Clinical Study Information Center
✉ GileadClinicalTrials@gilead.com📞 1-833-445-3230 (GILEAD-0)
Gilead Study Director
STUDY DIRECTOR
Gilead Sciences
Frequently Asked Questions
Who can join the NCT07473778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07473778 currently recruiting?
Yes, NCT07473778 is actively recruiting participants. Contact the research team at GileadClinicalTrials@gilead.com for enrollment information.
Where is the NCT07473778 trial being conducted?
This trial is being conducted at Beverly Hills, United States, San Diego, United States, West Hollywood, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT07473778 clinical trial?
NCT07473778 is sponsored by Gilead Sciences. The principal investigator is Gilead Study Director at Gilead Sciences. The trial plans to enroll 3,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.