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

NCT04871113 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-10-15

Study results available
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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

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

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2022-10-27
Completion
2023-09-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871113 on ClinicalTrials.gov