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bNAb+Cabotegravir v SOC Phase 2b
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Single Infusion of VH3810109 bNAb Controls HIV at Two Doses
VH3810109, a broadly neutralizing antibody (bNAb), promoted anti-HIV responses in 13 of 14 people with a single 40-mg/kg or 280-mg (∼4 mg/kg) infusion [1]. At the approximately 10-fold lower dose, 280 mg, VH3810109 was more efficacious and durable than other bNAbs given at similarly low doses.
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) (EMBRACE)
https://clinicaltrials.gov/study/NCT05996471
Study Overview
Brief 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.
OFFICIAL TITLE
A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV
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