Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
Public ClinicalTrials.gov record NCT07047716. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07047716
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 339 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2025 (Actual)
- Primary completion
- Sep 2028 (Estimated)
- Completion
- Sep 2028 (Estimated)
- Last update posted
- Aug 28, 2026
2025 – 2028
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Sexual Health Research Clinic | Birmingham | Alabama | 35233 | — |
| UCLA Clinic Care | Los Angeles | California | 90035 | — |
| Ruane Clinical Research Group, Inc. | Los Angeles | California | 90036 | — |
| UCLA Vine Street Clinic | Los Angeles | California | 90038 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| UCSD AntiViral Research Center (AVRC) | San Diego | California | 92103 | — |
| Bridge HIV, San Francisco Department of Public Health | San Francisco | California | 94102 | — |
| Yale University; School of Medicine; AIDS Program | New Haven | Connecticut | 06510 | — |
| Whitman-Walker Institute, Inc. | Washington D.C. | District of Columbia | 20009 | — |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| The ID Prevention Research Unit | Miami | Florida | 33136 | — |
| University of South Florida - Curran Children's Health Center | Tampa | Florida | 33606 | — |
| The Hope Clinic of Emory University | Atlanta | Georgia | 30030 | — |
| Ponce de Leon Center Clinical Research Site | Atlanta | Georgia | 30303 | — |
| University of Illinois-Chicago (UIC), Center for Dissemination and Implementation Sciences (CDIS) | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| University Medical Center | New Orleans | Louisiana | 70119 | — |
| Johns Hopkins Hospital - Clinical Research Unit | Baltimore | Maryland | 21287 | — |
| Fenway Health | Boston | Massachusetts | 02215 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Icahn School of Medicine at Mount Sinai - Clinical and Translational Research Center | New York | New York | 10029 | — |
| ICAP at Columbia University- Bronx Prevention Center | The Bronx | New York | 10451 | — |
| NC TraCS Institute - CTRC, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Penn Prevention Unit | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center | Philadelphia | Pennsylvania | 19107 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| The Crofoot Research Center | Houston | Texas | 77098 | — |
| Vaccine Trials Unit - Fred Hutchinson Cancer Center / University of Washington | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07047716, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07047716 live on ClinicalTrials.gov.