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NCT07047716 · ClinicalTrials.gov registry record · Phase 3
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
A Phase 3 study of HIV Pre-exposure Prophylaxis, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT07047716: Recruiting Phase 3 study of HIV Pre-exposure Prophylaxis, sponsored by Gilead Sciences.
NCT07047716 is a Phase 3 study of HIV Pre-exposure Prophylaxis that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 350 participants, below the 889-participant average among 8 other HIV Pre-exposure Prophylaxis trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07047716, a Phase 3 study of HIV Pre-exposure Prophylaxis, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Ctrough is defined as the concentration at the end of the dosing interval.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2028-09 |
| Phase | Phase 3 |
What NCT07047716 shows while recruiting
NCT07047716 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 889-participant average among 8 other HIV Pre-exposure Prophylaxis trials with a reported enrollment target (61% lower).
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.
NCT07047716 names 20 study sites across 9 states, led by California, Florida, District of Columbia.
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.
What interventions are being tested in trial NCT07047716?
The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG).
Who is sponsoring clinical trial NCT07047716?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for HIV Pre-exposure Prophylaxis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07047716's enrollment target sits among peer trials
350 5th of 8 higher than 3 of 8 other HIV Pre-exposure Prophylaxis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Pre-exposure Prophylaxis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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