Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06101329 · ClinicalTrials.gov registry record · Phase 2
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
A Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 253
- Enrollment target
- 11
- Study locations
NCT06101329: Active Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
NCT06101329 is a Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101329, a Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 253 participants
- Enrollment target
- 11
- Study locations
Study Summary
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
Primary Outcome
Ctrough is defined as the concentration at the end of the dosing interval.
Conditions Studied
Interventions
- DRUG Lenacapavir Injection
- DRUG Lenacapavir Tablet
- DRUG Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
Study Locations (11)
New York
- Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine - New York
- Harlem Prevention Center CRS - New York
- ICAP at Columbia University - Bronx Prevention Center - The Bronx
Alabama
- UAB, 1917 Research Clinic - Birmingham
California
- UCSD Antiviral Research Center (AVRC) - San Diego
District of Columbia
- George Washington University Medical Faculty Associates - Washington D.C.
Georgia
- Ponce de Leon Center Clinical Research Site - Atlanta
Massachusetts
- Fenway Health - Boston
New Jersey
- Rutgers New Jesey Medical School - Clinical Research Center - Newark
North Carolina
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2023-11-17 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What the registry record for NCT06101329 still lists
NCT06101329 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Pre-Exposure Prophylaxis of HIV Infection appearing as the primary indexed condition, and to 3 interventions - of which Lenacapavir Injection is the first listed.
NCT06101329 lists 11 locations in 9 states (New York, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT06101329 about?
NCT06101329 is a clinical study titled "Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)". The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in the US. The primary objectives of this study are: 1) to characterize th...
What is the current status of trial NCT06101329?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2023-11-17. Estimated completion is 2028-01.
What conditions does trial NCT06101329 study?
This clinical trial studies the following conditions: Pre-Exposure Prophylaxis of HIV Infection.
What interventions are being tested in trial NCT06101329?
The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG), Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) (DRUG).
Who is sponsoring clinical trial NCT06101329?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101329 being conducted?
This trial has 11 study locations across Alabama, California, District of Columbia, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pre-Exposure Prophylaxis of HIV Infection
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 NCT06101329's enrollment target sits among peer trials
253 220th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04390737 · 254 participants · Phase 1
Evaluate the Safety and Clinical Activity of HH2853
- NCT04677647 · 254 participants · NA
OurChild: A Health IT Solution to Reduce Minority Health Disparities
- NCT05503797 · 254 participants · Phase 2
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
- NCT06167317 · 254 participants · Phase 1
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI