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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 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. The trial reports 11 study locations across 9 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06101329
The ClinicalTrials.gov registry entry for NCT06101329 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 253 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 9 distinct geographic areas - top geographies include 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.
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