At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GSK3810109A and Dolutegravir+lamivudine SOC regimen for HIV Infections. Completed, enrolled 62 participants across 24 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
GSK3810109A available as sterile aqueous solution.
Dolutegravir+lamivudine regimen administered in consistence with investigator input and local guidelines