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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 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. The trial reports 9 study locations across 8 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06101342
The ClinicalTrials.gov registry entry for NCT06101342 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 181 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.
NCT06101342 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.