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Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

ClinicalTrials.gov ID: NCT06101342

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:50 PM EDT

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

Study identification

NCT ID
NCT06101342
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Gilead Sciences
Industry
Enrollment
181 participants

Conditions and interventions

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 12, 2023
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027
Last update posted
Mar 1, 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 Mar 1, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06101342 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →