Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
NCT04925752 · View on ClinicalTrials.gov ↗
Study Summary
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 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.
Conditions Studied
Interventions
- DRUG Oral Lenacapavir (LEN)
- DRUG F/TDF
- DRUG Sub-cutaneous (SC) Lenacapavir (LEN)
- DRUG Placebo SC LEN
- DRUG PTM F/TDF
Study Locations (20)
California
- Loma Linda University Clinical Trial Center Clinic — Loma Linda
- Ruane Clinical Research Group Inc. — Los Angeles
- UCLA CBAM Vine Street Clinic — Los Angeles
- Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC) — Los Angeles
- Mills Clinical Research — Los Angeles
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Los Angeles
- BIOS Clinical Research — Palm Springs
- UCSD Anti Viral Research Center — San Diego
- Bridge HIV at the San Francisco Department of Public Health — San Francisco
- Optimus Medical Group — San Francisco
Florida
- Therafirst Medical Center — Fort Lauderdale
- Gary Richmond, MD, PA — Fort Lauderdale
- Midway Immunology & Research Center, LLC — Ft. Pierce
- CAN Community Health Clinic — Jacksonville
- University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami — Miami
District of Columbia
- Whitman-Walker Institute Inc. — Washington D.C.
- Washington Health Institute — Washington D.C.
Alabama
- UAB Sexual Health Research Clinic — Birmingham
Colorado
- University of Colorado Clinical and Translational Research Centers (CTRC) — Aurora
Connecticut
- Yale University, School of Medicine — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,292 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2028-08 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04925752
The ClinicalTrials.gov registry entry for NCT04925752 describes a study currently listed as active not 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 3,292 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 Pre-Exposure Prophylaxis of HIV Infection appearing as the primary indexed condition, and to 5 interventions — of which Oral Lenacapavir (LEN) 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: NCT04925752 reports 20 study locations spanning 6 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 NCT04925752 about?
NCT04925752 is a clinical study titled "Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection". 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 stud...
What is the current status of trial NCT04925752?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3,292 participants. The study started on 2021-06-28. Estimated completion is 2028-08.
What conditions does trial NCT04925752 study?
This clinical trial studies the following conditions: Pre-Exposure Prophylaxis of HIV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04925752?
The interventions under investigation include: Oral Lenacapavir (LEN) (DRUG), F/TDF (DRUG), Sub-cutaneous (SC) Lenacapavir (LEN) (DRUG), Placebo SC LEN (DRUG), PTM F/TDF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04925752?
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 NCT04925752 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.