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ACTIVE NOT RECRUITING 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)

NCT06101329 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 253 participants
Start Date 2023-11-17
Est. Completion 2028-01
Phase Phase 2

Sponsor

Gilead Sciences

190 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06101329 reports 11 study locations spanning 9 distinct geographic areas — top geographies include New York, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06101329?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial