NCT04871113

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

A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	GSK3810109A	GSK3810109A available as sterile aqueous solution.
BIOLOGICAL	Dolutegravir+lamivudine SOC regimen	Dolutegravir+lamivudine regimen administered in consistence with investigator input and local guidelines

Timeline

• Start date: 2021-06-22
• Primary completion: 2022-10-27
• Completion: 2023-09-21
• First posted: 2021-05-04
• Last updated: 2024-10-15
• Results posted: 2023-11-18

Locations

24 sites across 6 countries: United States, Argentina, Brazil, Canada, Mexico, Peru

Regulatory

• FDA-regulated drug study