Clinical Trial

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Study acronym: EMBRACE
Active, Not Recruiting Phase 2
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Summary
The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-08-09; most recent amendment 2026-03-10.
Status change: Recruiting → Active, Not Recruiting 2024-04-01
Status change: Not Yet Recruiting → Recruiting 2023-08-28
Trial Details
NCT Number NCT05996471
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 185 participants
Start Date 2023-08-17
Primary Completion 2026-05-27 (estimated)
Study Completion 2028-11-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-29