Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With HIV Prevention Trials Network, National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID).
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Prevention
Enrollment
181actual
Sites
9
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 | 2023-12-13 | actual | When the study began enrolling |
| Primary completion | 2026-07-27 | 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 | 2026-08-13 | 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 Injection — also filed as GS-6207, Yeztugo®
- Drug: Lenacapavir Tablet — also filed as GS-6207
- 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): LEN Plasma concentration at the End of the Dosing Interval (Week 26)
measured Week 26
PK Parameter: Ctrough for LEN: LEN Plasma concentration at the End of the Dosing Interval (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 52
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities with LEN and F/TDF
measured First dose date up to 30 days post last dose at Week 52
Publications
- PMID 41498432 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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