Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
Public ClinicalTrials.gov record NCT06101342. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06101342
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 181 participants
Conditions and interventions
Conditions
Interventions
- Lenacapavir Injection Drug
- Lenacapavir Tablet Drug
- Emtricitabine/tenofovir disoproxil fumarate (F/TDF) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2023 (Actual)
- Primary completion
- Jul 27, 2026 (Actual)
- Completion
- Jan 2028 (Estimated)
- Last update posted
- Aug 13, 2026
2023 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Vine Street Clinic | Los Angeles | California | 90038 | — |
| UCSD AntiViral Research Center (AVRC) | San Diego | California | 92103 | — |
| University of Miami - Converge Miami Building | Miami | Florida | 33136 | — |
| Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research | Baltimore | Maryland | 21287 | — |
| Rutgers New Jersey Medical School, Department of Medicine | Newark | New Jersey | 07103 | — |
| ICAP at Columbia University- Bronx Prevention Center | The Bronx | New York | 10451 | — |
| University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit | Philadelphia | Pennsylvania | 19104 | — |
| Houston AIDS Research Team CRS | Houston | Texas | 77030 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06101342, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06101342 live on ClinicalTrials.gov.