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NCT06101342 · ClinicalTrials.gov registry record · Phase 2
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
A Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
- 9
- Study locations
NCT06101342: Active Phase 2 study of Pre-Exposure Prophylaxis of HIV Infection, sponsored by Gilead Sciences.
NCT06101342 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 181 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101342, 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
- 181 participants
- Enrollment target
- 9
- Study locations
Study Summary
The goals of this clinical study are 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 pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). The primary objectives of this study are to characterize the pharmacokinetics (PK) of LEN and to evaluate the safety of LEN and F/TDF for PrEP in US PWID.
Conditions Studied
Interventions
- DRUG Lenacapavir Injection
- DRUG Lenacapavir Tablet
- DRUG Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Study Locations (9)
California
- UCLA Vine Street Clinic - Los Angeles
- UCSD AntiViral Research Center (AVRC) - San Diego
Florida
- University of Miami - Converge Miami Building - Miami
Maryland
- Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research - Baltimore
New Jersey
- Rutgers New Jersey Medical School, Department of Medicine - Newark
New York
- ICAP at Columbia University- Bronx Prevention Center - The Bronx
Pennsylvania
- University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit - Philadelphia
Texas
- Houston AIDS Research Team CRS - Houston
West Virginia
- West Virginia University - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What the registry record for NCT06101342 still lists
NCT06101342 is an interventional study that assigns participants to a tested intervention. The registered 181 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 (36% 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.
NCT06101342 lists 9 locations in 8 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT06101342 about?
NCT06101342 is a clinical study titled "Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)". The goals of this clinical study are 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 pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). The primary objectiv...
What is the current status of trial NCT06101342?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2023-12-13. Estimated completion is 2028-01.
What conditions does trial NCT06101342 study?
This clinical trial studies the following conditions: Pre-Exposure Prophylaxis of HIV Infection.
What interventions are being tested in trial NCT06101342?
The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG), Emtricitabine/tenofovir disoproxil fumarate (F/TDF) (DRUG).
Who is sponsoring clinical trial NCT06101342?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101342 being conducted?
This trial has 9 study locations across California, Florida, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06101342's enrollment target sits among peer trials
181 365th of 2000 higher than 1,636 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
-
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
ACTIVE NOT RECRUITING · Phase 2
-
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
ACTIVE NOT RECRUITING · Phase 3
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