A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Summary

This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.

Timeline

Start

2021-06-22

Primary completion

2022-10-27

Completion

2023-09-21

Publications

• Leone PA, Ferro A, Rolle CP, Lupo S, McGowan J, Klein M, Cahn P, Benson P, Griesel R, Warwick-Sanders M, Sanchez M, D'Agostino R, Bettacchi C, Schneider S, Wannamaker P, Dorey D, Wilches V, Gartland M, Brown K, Gandhi Y, Donatti C, Losos J. VH3810109 Efficacy, Safety, Pharmacokinetics, and Incidence of Antidrug Antibodies in Adults With HIV-1 Naive to Antiretroviral Therapy: BANNER Study Results. J Infect Dis. 2025 Dec 20;232(6):e1022-e1032. doi: 10.1093/infdis/jiaf450.
• Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.

Drugs

Indications