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NCT04925752 · ClinicalTrials.gov registry record · Phase 3
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
A Phase 3 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 3,292
- Enrollment target
- 20
- Study locations
NCT04925752: Active Phase 3 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
NCT04925752 is a Phase 3 study of Pre-Exposure Prophylaxis of HIV Infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 3,292 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (326% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04925752, a Phase 3 study of Pre-Exposure Prophylaxis of HIV Infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,292 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
bHIV per 100 PY in the Incidence Phase was calculated using RITA. The RITA incorporated HIV-1 testing results and recency assay testing results to estimate the bHIV. Recency assay testing was performed for participants in the All Screened Set found to have HIV-1 infection at the Incidence Phase Screening Visit as defined below. Participants were considered to have recent HIV-1 infection if the normalized optical density (ODn) was below 1.5 threshold using the Sedia limiting antigen avidity enzym
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 |
What the registry record for NCT04925752 still lists
NCT04925752 is an interventional study that assigns participants to a tested intervention. Its 3,292 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (326% higher).
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.
NCT04925752 names 20 study sites across 6 states, led by California, Florida, District of Columbia.
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.
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).
Who is sponsoring clinical trial NCT04925752?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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
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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 NCT04925752's enrollment target sits among peer trials
3,292 72nd of 2000 higher than 1,929 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
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-
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
ACTIVE NOT RECRUITING · Phase 2
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