Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With HIV Prevention Trials Network.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Prevention
Enrollment
253actual
Sites
11
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-17 | actual | When the study began enrolling |
| Primary completion | 2026-07-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pre-Exposure Prophylaxis of HIV Infection
Interventions
- Drug: Lenacapavir Tablet — also filed as GS-6207
- Drug: Lenacapavir Injection — also filed as GS-6207, Yeztugo®
- Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) — also filed as Truvada®
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26
measured Week 26
PK Parameter: Ctrough for LEN at the End of Week 52
measured Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
measured First dose date up to 30 days post last dose at Week 78
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
measured First dose date up to 30 days post last dose at Week 78
General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
measured Up to Week 52
Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
measured Up to Week 52
Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
measured Up to Week 52
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