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RECRUITING Phase 3

Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)

NCT07047716 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP. The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.

Interventions

  • DRUG Lenacapavir Injection
  • DRUG Lenacapavir Tablet

Study Locations (20)

California

  • UCLA Clinic Care — Los Angeles
  • Ruane Clinical Research Group, Inc. — Los Angeles
  • UCLA Vine Street Clinic — Los Angeles
  • Mills Clinical Research — Los Angeles
  • BIOS Clinical Research — Palm Springs
  • UCSD AntiViral Research Center (AVRC) — San Diego
  • Bridge HIV, San Francisco Department of Public Health — San Francisco

Florida

  • Midway Immunology and Research Center — Ft. Pierce
  • The ID Prevention Research Unit — Miami
  • University of South Florida - Curran Children's Health Center — Tampa

District of Columbia

  • Whitman-Walker Institute, Inc. — Washington D.C.
  • Children's National Hospital — Washington D.C.

Georgia

  • The Hope Clinic of Emory University — Atlanta
  • Ponce de Leon Center Clinical Research Site — Atlanta

Illinois

  • University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS) — Chicago
  • Howard Brown Health Center — Chicago

Alabama

  • UAB Sexual Health Research Clinic — Birmingham

Connecticut

  • Yale University; School of Medicine; AIDS Program — New Haven

Louisiana

  • University Medical Center — New Orleans

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2025-07-22
Est. Completion 2028-09
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07047716

The ClinicalTrials.gov registry entry for NCT07047716 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HIV Pre-exposure Prophylaxis appearing as the primary indexed condition, and to 2 interventions — of which Lenacapavir Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07047716 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07047716 about?

NCT07047716 is a clinical study titled "Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)". The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in peop...

What is the current status of trial NCT07047716?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2025-07-22. Estimated completion is 2028-09.

What conditions does trial NCT07047716 study?

This clinical trial studies the following conditions: HIV Pre-exposure Prophylaxis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07047716?

The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07047716?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07047716 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial