A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit from PrEP

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507891-31-00

Acronym

GS-US-528-6727

Enrollment

112

Registered

2024-08-21

Start date

2024-10-11

Completion date

Unknown

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV-1) infection

Brief summary

On-time LEN injection at Day 1/baseline and Week 26 and on-time follow-up visit at Week 52, Dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations consistent with ≥ 4 doses/week (≥ 700 fmol/punch) at Weeks 13, 26, 39, and 52

Detailed description

Treatment-emergent adverse events and treatment emergent laboratory abnormalities, Questionnaire outcomes related to general acceptability of LEN and F/TDF, LEN plasma concentrations at Weeks 26 and 52

Interventions

DRUGSunlenca 464 mg solution for injection

DRUGTENOFOVIR DISOPROXIL AND EMTRICITABINE

DRUGSunlenca 300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Treatment-emergent adverse events and treatment emergent laboratory abnormalities, Questionnaire outcomes related to general acceptability of LEN and F/TDF, LEN plasma concentrations at Weeks 26 and 52	—

Primary

Measure	Time frame
On-time LEN injection at Day 1/baseline and Week 26 and on-time follow-up visit at Week 52, Dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations consistent with ≥ 4 doses/week (≥ 700 fmol/punch) at Weeks 13, 26, 39, and 52	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026