Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
Public ClinicalTrials.gov record NCT06101329. 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, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06101329
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 253 participants
Conditions and interventions
Conditions
Interventions
- Lenacapavir Tablet Drug
- Lenacapavir Injection Drug
- Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Nov 17, 2023 (Actual)
- Primary completion
- Jul 22, 2026 (Actual)
- Completion
- Jan 2028 (Estimated)
- Last update posted
- Aug 17, 2026
2023 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB, 1917 Research Clinic | Birmingham | Alabama | 35222 | — |
| UCSD Antiviral Research Center (AVRC) | San Diego | California | 92103 | — |
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Ponce de Leon Center Clinical Research Site | Atlanta | Georgia | 30303 | — |
| Fenway Health | Boston | Massachusetts | 02215 | — |
| Rutgers New Jesey Medical School - Clinical Research Center | Newark | New Jersey | 07103 | — |
| Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine | New York | New York | 10010 | — |
| Harlem Prevention Center CRS | New York | New York | 10027 | — |
| ICAP at Columbia University - Bronx Prevention Center | The Bronx | New York | 10451 | — |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Penn Prevention Research Unit | Philadelphia | Pennsylvania | 19104 | — |
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 NCT06101329, 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 17, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06101329 live on ClinicalTrials.gov.