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NCT07473778 · ClinicalTrials.gov registry record

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

A clinical trial, sponsored by Gilead Sciences.

Recruiting
Registry status
3,000
Enrollment target

NCT07473778: Recruiting study, sponsored by Gilead Sciences.

NCT07473778 is a clinical trial that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 3,000 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07473778 is actively recruiting participants, sponsored by Gilead Sciences.

RECRUITING
Registry status
3,000 participants
Enrollment target

Study 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.

Primary Outcome

LEN PrEP persistence at Week 52 is defined as the proportion of participants receiving a LEN injection at enrollment who had an on-time injection at Week 26 and an on-time Week 52 visit ('on time' is defined as ≤ 28 weeks from the last injection).

Interventions

  • DRUG Lenacapavir Injection
  • DRUG Lenacapavir Tablet
  • DRUG Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
  • DRUG Cabotegravir (CAB)
  • DRUG Emtricitabine/tenofovir alafenamide (F/TAF)

Trial Details

FieldValue
Enrollment Target 3,000 participants
Start Date 2026-03-17
Est. Completion 2029-04
Gilead Sciences

504 total trials

What NCT07473778 shows while recruiting

NCT07473778 is an observational study that tracks outcomes without assigning an intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 5 interventions - of which Lenacapavir Injection is the first listed.

NCT07473778 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07473778 about?

NCT07473778 is a clinical study titled "Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention". 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 c...

What is the current status of trial NCT07473778?

This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2026-03-17. Estimated completion is 2029-04.

What interventions are being tested in trial NCT07473778?

The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG), Emtricitabine/tenofovir disoproxil fumarate (F/TDF) (DRUG), Cabotegravir (CAB) (DRUG), Emtricitabine/tenofovir alafenamide (F/TAF) (DRUG).

Who is sponsoring clinical trial NCT07473778?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT07473778, the US trial registry maintained by the National Library of Medicine. NCT07473778 (large enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.