Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
Public ClinicalTrials.gov record NCT04925752. 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, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 pre-exposure prophylaxis (PrEP) in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.
Study identification
- NCT ID
- NCT04925752
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,292 participants
Conditions and interventions
Conditions
Interventions
- Oral Lenacapavir (LEN) Drug
- F/TDF Drug
- Sub-cutaneous (SC) Lenacapavir (LEN) Drug
- Placebo SC LEN Drug
- PTM F/TDF Drug
- PTM Oral LEN Drug
- F/TAF (for US participants only) Drug
Drug
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
- Jun 28, 2021 (Actual)
- Primary completion
- Aug 21, 2024 (Actual)
- Completion
- Aug 2028 (Estimated)
- Last update posted
- Oct 6, 2026
2021 – 2028
United States locations
- U.S. sites
- 60
- U.S. states
- 25
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Sexual Health Research Clinic | Birmingham | Alabama | 35233 | — |
| Loma Linda University Clinical Trial Center Clinic | Loma Linda | California | 92354 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| UCLA CBAM Vine Street Clinic | Los Angeles | California | 90038 | — |
| Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC) | Los Angeles | California | 90059 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Los Angeles | California | 90502 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| UCSD Anti Viral Research Center | San Diego | California | 92103 | — |
| Bridge HIV at the San Francisco Department of Public Health | San Francisco | California | 94102 | — |
| Optimus Medical Group | San Francisco | California | 94102 | — |
| University of Colorado Clinical and Translational Research Centers (CTRC) | Aurora | Colorado | 80045 | — |
| Yale University, School of Medicine | New Haven | Connecticut | 06510 | — |
| Whitman-Walker Institute Inc. | Washington D.C. | District of Columbia | 20009 | — |
| Washington Health Institute | Washington D.C. | District of Columbia | 20017 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Gary Richmond, MD, PA | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | — |
| CAN Community Health Clinic | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami | Miami | Florida | 33136 | — |
| CAN Community Health | Miami Gardens | Florida | 33055 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| CAN Community Health | Sarasota | Florida | 34237 | — |
| The Hope Clinic at Emory University | Atlanta | Georgia | 30030 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Emory University Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | — |
| RMR Core Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH | Chicago | Illinois | 60612 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Indiana University Infectious Diseases Research | Indianapolis | Indiana | 46202 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Norton Infectious Disease Specialists | Louisville | Kentucky | 40241 | — |
| LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center | New Orleans | Louisiana | 70119 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| The Fenway Institute | Boston | Massachusetts | 02215 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Open Arms Healthcare Center | Jackson | Mississippi | 39202 | — |
| KC CARE Health Center | Kansas City | Missouri | 64111 | — |
| St. Michael's Medical Center | Newark | New Jersey | 07102 | — |
| South Jersey Infectious Disease | Somers Point | New Jersey | 08244 | — |
| Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown | New York | New York | 10029 | — |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Cone Health/Regional Center for Infectious Disease Research Center | Greensboro | North Carolina | 27401 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Penn Prevention Unit | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina, Infectious Disease Clinic | Charleston | South Carolina | 29425 | — |
| Prisma Health-Midlands Clinical Research Unit | Columbia | South Carolina | 29203 | — |
| Prisma Health Internal Medicine Clinic | Greenville | South Carolina | 29605 | — |
| Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center | Memphis | Tennessee | 38103 | — |
| St Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Meharry Medical College Clinical and Transitional Research Center | Nashville | Tennessee | 37208 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| Centro San Vincente | El Paso | Texas | 79915 | — |
| UT Health Science Center at Houston | Houston | Texas | 77009 | — |
| The Crofoot Research Center, INC | Houston | Texas | 77098 | — |
| Ofiice of Dr. Peter Shalit, MD | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04925752, 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 Oct 6, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04925752 live on ClinicalTrials.gov.